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Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix

Primary Purpose

Edentulous Alveolar Ridge

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Volume-stable collagen matrix Geistlich Fibro-Gide®
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Soft tissue augmentation, Immediate implant, Collagen matrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.

Exclusion Criteria:

  • Patients who are heavy smokers (more than 10 cigarettes/day);
  • Patients who suffer from any systemic diseases that could negatively influence wound healing;
  • Patients who received head and neck radiation treatment;
  • Patients who have a full contraindication to implant surgery;
  • Patients who have uncontrolled periodontal disease;
  • Patients who show a full mouth plaque and bleeding score higher than 25%;
  • Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008.
  • Patients with known allergy, sensitivity or intolerance to collagen
  • Patients who are pregnant or who are breastfeeding

Sites / Locations

  • U.O. Odontostomatologia e Chirurgia del Cavo OraleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Test Group

Arm Description

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures.

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures

Outcomes

Primary Outcome Measures

Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Soft Tissue Thickness (STT)
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)

Secondary Outcome Measures

Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Vertical position of soft tissue (VPS)
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Assessment of the linear volumetric changes
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Pink Esthetic Score (PES)
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Papillae index (PI)
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Width of keratinized tissue (WKT)
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Peri-implant marginal bone level (MBL)
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Phenotype
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect. The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Probing pocket depth (PD)
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Modified Plaque Index (mPI)
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Gingival bleeding on probing (BoP)
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Implant success
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Biological and technical complication
Complications from biological and technical nature (Pjetursson et al. 2012).
Surgery time
The surgery time will be recorded in both groups to the closest minute from the start of the first incision to the accomplishment of the last suture.
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Patient satisfaction OHIP-14
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Patient satisfaction VAS
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.

Full Information

First Posted
September 20, 2021
Last Updated
May 9, 2023
Sponsor
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT05081284
Brief Title
Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix
Official Title
Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study. Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix. Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
Soft tissue augmentation, Immediate implant, Collagen matrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures.
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures
Intervention Type
Device
Intervention Name(s)
Volume-stable collagen matrix Geistlich Fibro-Gide®
Other Intervention Name(s)
Geistlich Fibro-Gide, G1 039446 0086 Rev. 00 G7 16 07 39446 073
Intervention Description
After tooth extraction and implant insertion the Test group will receive a soft tissue augmentation on the buccal side oh the implant. an envelop flap will be raised and a volume-stable collagen graft will be stabilized with sutures. Control group will not receive soft tissue augmentation.
Primary Outcome Measure Information:
Title
Soft Tissue Thickness (STT)
Description
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time Frame
T0a: baseline before surgery
Title
Soft Tissue Thickness (STT)
Description
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time Frame
T0b: baseline after surgery
Title
Soft Tissue Thickness (STT)
Description
Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)
Time Frame
T2: 12 months after implant placement
Secondary Outcome Measure Information:
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T0a: baseline before surgery
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T0b: baseline after surgery
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T2: 12 months after surgery
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T3: 24 months after surgery
Title
Vertical position of soft tissue (VPS)
Description
A tooth-supported Essix stent will be used to record the distance from three reference marks (mesial papilla, midbuccal margin, and distal papilla) to the free gingival margin using a color-coded probe (15mm, UNC). The same stent will be used for measurements at the different follow-up visits. (Bittner et al. 2020)
Time Frame
T4: 36 months after surgery
Title
Assessment of the linear volumetric changes
Description
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time Frame
T0a: baseline before surgery
Title
Assessment of the linear volumetric changes
Description
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Assessment of the linear volumetric changes
Description
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time Frame
T2: 12 months after surgery
Title
Assessment of the linear volumetric changes
Description
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time Frame
T3: 24 months after surgery
Title
Assessment of the linear volumetric changes
Description
Impressions of the grafted sites will be taken including at least the two neighboring teeth and using a silicone impression material. Dental stone casts will be fabricated and optically scanned with a desktop 3D scanner. Digital models of each time-point per patient will be captured as stereolithography (STL) files. The images of the baseline and follow-up datasets will be superimposed and matched using the best-fit algorithm at the adjacent tooth surfaces. After definition of specific regions of interest (ROI), the software will calculated the volumetric changes measured in mm, which will correspond to the mean distance between the three surfaces representing the evaluated time-points. One buccal ROI will be defined: a trapezoid shape area between the gingival margins of the adjacent teeth, the mucogingival junction as apical and the interproximal areas as lateral borders. The measured will be kept constant in each patient and site over time. (Zeltner 2017)
Time Frame
T4: 36 months after surgery
Title
Pink Esthetic Score (PES)
Description
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Pink Esthetic Score (PES)
Description
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time Frame
T2: 12 months after surgery
Title
Pink Esthetic Score (PES)
Description
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time Frame
T3: 24 months after surgery
Title
Pink Esthetic Score (PES)
Description
PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue colour and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The papillae values will be evaluated for completeness, incompleteness or absence. Other variables will be assessed by comparison with a reference tooth. The highest possible score reflecting a perfect match of the peri-implant soft tissue with that of the reference tooth will be 14. (Furhauser et al. 2005)
Time Frame
T4: 36 months after surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T0a: baseline before surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T0b: baseline after surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T2: 12 months after surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T3: 24 months after surgery
Title
Papillae index (PI)
Description
The statuses of the mesial and distal papilla will be assessed using the Papillae index (from 0 to 3). (Jemt et al. 1997)
Time Frame
T4: 36 months after surgery
Title
Width of keratinized tissue (WKT)
Description
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time Frame
T0a: baseline before surgery
Title
Width of keratinized tissue (WKT)
Description
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Width of keratinized tissue (WKT)
Description
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time Frame
T2: 12 months after surgery
Title
Width of keratinized tissue (WKT)
Description
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time Frame
T3: 24 months after surgery
Title
Width of keratinized tissue (WKT)
Description
WKT will be measured, with a periodontal probe (mm), mid-facially from the gingival margin to the muco-gingival junction of the intended extracted tooth or the implant supported restoration.
Time Frame
T4: 36 months after surgery
Title
Peri-implant marginal bone level (MBL)
Description
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time Frame
T0b: baseline after surgery
Title
Peri-implant marginal bone level (MBL)
Description
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Peri-implant marginal bone level (MBL)
Description
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time Frame
T2: 12 months after surgery
Title
Peri-implant marginal bone level (MBL)
Description
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time Frame
T3: 24 months after surgery
Title
Peri-implant marginal bone level (MBL)
Description
MBL will be measured on intraoral radiographs at the mesial and distal aspects (m and d). It will be set as the distance between the reference point and the most apical point of contact between the implant surface and the bone. The reference point will be the fixture-abutment interface. Digital intraoral periapical radiographs will be taken using a parallel cone technique with digital sensor. A paralleling device and individualized bite blocks made of polyvinyl siloxane impression material will be used for the standardization of the X-ray geometry. Calibration will be performed using the known thread-pitch distance of the implants. Measurements will be taken to the nearest millimeter using computer software.
Time Frame
T4: 36 months after surgery
Title
Phenotype
Description
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time Frame
T0a: baseline before surgery
Title
Phenotype
Description
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Phenotype
Description
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time Frame
T2: 12 months after surgery
Title
Phenotype
Description
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time Frame
T3: 24 months after surgery
Title
Phenotype
Description
It will be based on the lack of transparency of a periodontal probe through the gingival margin when probing the buccal sulcus of the failing tooth (De Rouck et al. 2009).
Time Frame
T4: 36 months after surgery
Title
Probing pocket depth (PD)
Description
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect. The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time Frame
T0a: baseline before surgery
Title
Probing pocket depth (PD)
Description
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Probing pocket depth (PD)
Description
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time Frame
T2: 12 months after surgery
Title
Probing pocket depth (PD)
Description
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time Frame
T3: 24 months after surgery
Title
Probing pocket depth (PD)
Description
probing pocket depth using a manual periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect.The distance measured from the base of the pocket to the most apical point on the gingival margin, expressed in millimeters (Mombelli et al., 1987).
Time Frame
T4: 36 months after surgery
Title
Modified Plaque Index (mPI)
Description
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time Frame
T0a: baseline before surgery
Title
Modified Plaque Index (mPI)
Description
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Modified Plaque Index (mPI)
Description
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time Frame
T2: 12 months after surgery
Title
Modified Plaque Index (mPI)
Description
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time Frame
T3: 24 months after surgery
Title
Modified Plaque Index (mPI)
Description
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. (Mombelli et al., 1987);
Time Frame
T4: 36 months after surgery
Title
Gingival bleeding on probing (BoP)
Description
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time Frame
T0a: baseline before surgery
Title
Gingival bleeding on probing (BoP)
Description
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Gingival bleeding on probing (BoP)
Description
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time Frame
T2: 12 months after surgery
Title
Gingival bleeding on probing (BoP)
Description
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time Frame
T3: 24 months after surgery
Title
Gingival bleeding on probing (BoP)
Description
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (Mombelli et al., 1987).
Time Frame
T4: 36 months after surgery
Title
Implant success
Description
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Implant success
Description
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time Frame
T2: 12 months after surgery
Title
Implant success
Description
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time Frame
T3: 24 months after surgery
Title
Implant success
Description
Implant failure and Implant success criteria will be recorded according to Buser et al.1990.
Time Frame
T4: 36 months after surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T0a: baseline before surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T0b: baseline after surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T2: 12 months after surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T3: 24 months after surgery
Title
Biological and technical complication
Description
Complications from biological and technical nature (Pjetursson et al. 2012).
Time Frame
T4: 36 months after surgery
Title
Surgery time
Description
The surgery time will be recorded in both groups to the closest minute from the start of the first incision to the accomplishment of the last suture.
Time Frame
T0a-b: baseline
Title
Patient satisfaction OHIP-14
Description
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Time Frame
T0a: baseline before surgery
Title
Patient satisfaction OHIP-14
Description
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Patient satisfaction OHIP-14
Description
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Time Frame
T2: 12 months after surgery
Title
Patient satisfaction OHIP-14
Description
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Time Frame
T3: 24 months after surgery
Title
Patient satisfaction OHIP-14
Description
The Oral Health Impact Profile (OHIP-14) is a questionnaire addressed the following domains: functional limitation, physical pain, psychological discomfort, physical disability, psycho- logical disability, social disability and handicap. These domains were evaluated by 2 questions each and scored by means of a 5-point Likert scale resulting in a total OHIP score ranging from 14 to 70 with higher scores being indicative of more discomfort in daily life. (Slade & Spencer, 1994)
Time Frame
T4: 36 months after surgery
Title
Patient satisfaction VAS
Description
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time Frame
T0a: baseline before surgery
Title
Patient satisfaction VAS
Description
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time Frame
T1: 2 weeks after crown delivery, 4 months from surgery
Title
Patient satisfaction VAS
Description
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time Frame
T2: 12 months after surgery
Title
Patient satisfaction VAS
Description
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time Frame
T3: 24 months after surgery
Title
Patient satisfaction VAS
Description
Patients were asked to respond to the following question on a Visual analogic scale: "How satisfied are you with the overall aesthetic result?" and "How satisfied are you with the overall functional result?"."Most unsatisfied" and "most satisfied" were indicated as extremes on the 100-mm lines.
Time Frame
T4: 36 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies. Exclusion Criteria: Patients who are heavy smokers (more than 10 cigarettes/day); Patients who suffer from any systemic diseases that could negatively influence wound healing; Patients who received head and neck radiation treatment; Patients who have a full contraindication to implant surgery; Patients who have uncontrolled periodontal disease; Patients who show a full mouth plaque and bleeding score higher than 25%; Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008. Patients with known allergy, sensitivity or intolerance to collagen Patients who are pregnant or who are breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Barone, DDS
Phone
050993327
Email
antonio.barone@unipi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Barone, DDS
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O. Odontostomatologia e Chirurgia del Cavo Orale
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Barone, Professor
Phone
050993327
Email
antonio.barone@unipi.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28548210
Citation
Cairo F, Barbato L, Tonelli P, Batalocco G, Pagavino G, Nieri M. Xenogeneic collagen matrix versus connective tissue graft for buccal soft tissue augmentation at implant site. A randomized, controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):769-776. doi: 10.1111/jcpe.12750. Epub 2017 Jun 29.
Results Reference
result
PubMed Identifier
31815977
Citation
Bittner N, Planzos L, Volchonok A, Tarnow D, Schulze-Spate U. Evaluation of Horizontal and Vertical Buccal Ridge Dimensional Changes After Immediate Implant Placement and Immediate Temporization With and Without Bone Augmentation Procedures: Short-Term, 1-Year Results. A Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2020 Jan/Feb;40(1):83-93. doi: 10.11607/prd.4152.
Results Reference
result
PubMed Identifier
28107560
Citation
Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11.
Results Reference
result
PubMed Identifier
16307569
Citation
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Results Reference
result
PubMed Identifier
9497723
Citation
Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.
Results Reference
result
PubMed Identifier
19419444
Citation
De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.
Results Reference
result
PubMed Identifier
3507627
Citation
Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
Results Reference
result
PubMed Identifier
2099210
Citation
Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
Results Reference
result
PubMed Identifier
23062125
Citation
Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.
Results Reference
result
PubMed Identifier
21491763
Citation
van der Meulen MJ, Lobbezoo F, John MT, Naeije M. [Oral health impact profile. an instrument for measuring the impact of oral health on the quality of life]. Ned Tijdschr Tandheelkd. 2011 Mar;118(3):134-9. doi: 10.5177/ntvt.2011.03.10178. Dutch.
Results Reference
result

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Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix

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