Timing of Soft Tissue Grafting Following Immediate Implant Placement
Primary Purpose
Bone Resorption
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Soft tissue grafting
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption focused on measuring dental implant, single tooth, immediate, connective tissue graft
Eligibility Criteria
Inclusion Criteria:
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
- Intact buccal bone wall at the time of extraction
- Written informed consent
Exclusion Criteria:
- Pregnancy
- Systemic diseases
- Smoking
- Suppuration
- > 1 mm gingival asymmetry between the failing and contralateral tooth
- Untreated periodontal disease; untreated caries lesions
Sites / Locations
- Ghent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immediate soft tissue grafting
Delayed soft tissue grafting
Arm Description
A connective tissue graft is immediately harvested and inserted in the buccal mucosa at the moment of implant placement
Three months after implant placement, a connective tissue graft is harvested and inserted in the buccal mucosa
Outcomes
Primary Outcome Measures
Buccal bone resorption (mm)
Changes in buccal bone dimension as measured on superimposed CBCT slides
Secondary Outcome Measures
Changes in buccal soft tissue profile (mm)
Changes in buccal soft tissue profile as measured on superimposed digital surface models. An intra-oral scan is taken prior to implant surgery and at 1- and 5- year follow up. On the obtained digital models, an area of interest (AOI) at the buccal aspect was drawn for each site. The AOI extends from 0.5 mm below the soft tissue margin to 4 mm more apical. In mesio-distal dimension, the AOI reaches from the mesial to the distal line angle. The AOI may vary between sites because of individual anatomic differences but must be kept constant in each site across time points. A volumetric change (mm3) was calculated by designated software within the AOI and divided by the AOI surface (mm2). This results in the mean change in buccal soft tissue profile (mm).
Changes in midfacial soft tissue level (mm)
Changes in buccal mucosal margin position as measured on superimposed digital surface models
Pink Esthetic Score
Pink Esthetic score as defined by Fürhauser et al., 2005. Within this scale, 7 variables are evaluated ( mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14. A 0 relates to the least esthetic result, while a 14 relates to a perfect outcome for all parameters.
Mucosal Scarring Index
Mucosal Scarring Index as defined by Wessels et al., 2019. Within this scale, 5 parameters are assessed (width, height/contour, color, suture marks, and overall appearance) using a 0-1-2 scoring system. The MSI score may range from 0 (no scar) to 10 (most extreme scar).
Marginal bone level changes (mm)
Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs
Probing depth (mm)
Measured with a periodontal probe at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant at 1- and 5-year follow-up. Measurements are rounded up to the nearest 0.5 mm. A mean value is calculated per implant.
Plaque (%)
Presence of plaque at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Bleeding on probing (%)
Presence of bleeding on probing at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05537545
Brief Title
Timing of Soft Tissue Grafting Following Immediate Implant Placement
Official Title
A Randomized Controlled Trial on the Timing of Soft Tissue Grafting Following Immediate Implant Placement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
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
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage.
In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group).
Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability.
In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later.
In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above.
A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.
Detailed Description
Patients with a single failing tooth in the anterior maxilla will be included after a clinical examination and evaluation of a small-field low-dose CBCT. An intra-oral scan will be taken in order to make a surgical guide. A cutting implant with variable thread design (BLX, Straumann) will be installed using the surgical guide in order to sufficient primary implant stability.
Thereafter, the gap between the implant surface and buccal bone wall is filled with deproteinized bovine bone mineral (Bio-Oss, Gheistlich Pharma).
At this point, a closed envelope is opened and the patient gets assigned to either ISG or DSG group.
In the immediate soft tissue grafting group, a de-epithelialized free gingival graft was inserted in a buccal pouch to augment the buccal soft tissues. The graft was fixed with single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany).
In the delayed soft tissue grafting group, the same procedure was performed 3 months after implant placement.
In both groups, patients received an immediate, screw-retained temporary crown. Restorations were installed within the first 48h after implant placement.
Sutures were removed 1 week after soft tissue grafting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
Keywords
dental implant, single tooth, immediate, connective tissue graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
As this RCT concerns a surgical intervention, patients and treating clinicians can not be masked.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate soft tissue grafting
Arm Type
Active Comparator
Arm Description
A connective tissue graft is immediately harvested and inserted in the buccal mucosa at the moment of implant placement
Arm Title
Delayed soft tissue grafting
Arm Type
Experimental
Arm Description
Three months after implant placement, a connective tissue graft is harvested and inserted in the buccal mucosa
Intervention Type
Procedure
Intervention Name(s)
Soft tissue grafting
Intervention Description
A pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany) onto the buccal mucosa.
Primary Outcome Measure Information:
Title
Buccal bone resorption (mm)
Description
Changes in buccal bone dimension as measured on superimposed CBCT slides
Time Frame
1-, 5-year
Secondary Outcome Measure Information:
Title
Changes in buccal soft tissue profile (mm)
Description
Changes in buccal soft tissue profile as measured on superimposed digital surface models. An intra-oral scan is taken prior to implant surgery and at 1- and 5- year follow up. On the obtained digital models, an area of interest (AOI) at the buccal aspect was drawn for each site. The AOI extends from 0.5 mm below the soft tissue margin to 4 mm more apical. In mesio-distal dimension, the AOI reaches from the mesial to the distal line angle. The AOI may vary between sites because of individual anatomic differences but must be kept constant in each site across time points. A volumetric change (mm3) was calculated by designated software within the AOI and divided by the AOI surface (mm2). This results in the mean change in buccal soft tissue profile (mm).
Time Frame
1-, 5-year
Title
Changes in midfacial soft tissue level (mm)
Description
Changes in buccal mucosal margin position as measured on superimposed digital surface models
Time Frame
1-, 5-year
Title
Pink Esthetic Score
Description
Pink Esthetic score as defined by Fürhauser et al., 2005. Within this scale, 7 variables are evaluated ( mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14. A 0 relates to the least esthetic result, while a 14 relates to a perfect outcome for all parameters.
Time Frame
1-year
Title
Mucosal Scarring Index
Description
Mucosal Scarring Index as defined by Wessels et al., 2019. Within this scale, 5 parameters are assessed (width, height/contour, color, suture marks, and overall appearance) using a 0-1-2 scoring system. The MSI score may range from 0 (no scar) to 10 (most extreme scar).
Time Frame
1-year
Title
Marginal bone level changes (mm)
Description
Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs
Time Frame
1-,5-year
Title
Probing depth (mm)
Description
Measured with a periodontal probe at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant at 1- and 5-year follow-up. Measurements are rounded up to the nearest 0.5 mm. A mean value is calculated per implant.
Time Frame
1-,5-year
Title
Plaque (%)
Description
Presence of plaque at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Time Frame
1-,5-year
Title
Bleeding on probing (%)
Description
Presence of bleeding on probing at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Time Frame
1-,5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 20 years old
Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
Intact buccal bone wall at the time of extraction
Written informed consent
Exclusion Criteria:
Pregnancy
Systemic diseases
Smoking
Suppuration
> 1 mm gingival asymmetry between the failing and contralateral tooth
Untreated periodontal disease; untreated caries lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Cosyn, Professor
Phone
+3293324000
Email
jan.cosyn@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz Seyssens, Phd candidate
Email
lorenz.seyssens@ugent.be
Facility Information:
Facility Name
Ghent University
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Cosyn, Professor
Email
jan.cosyn@ugent.be
First Name & Middle Initial & Last Name & Degree
Lorenz Seyssens, Phd candidate
Email
lorenz.seyssens@ugent.be
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
4500182
Citation
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
Results Reference
background
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
background
PubMed Identifier
32918332
Citation
Zuiderveld EG, van Nimwegen WG, Meijer HJA, Jung RE, Muhlemann S, Vissink A, Raghoebar GM. Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial. J Periodontol. 2021 Apr;92(4):553-561. doi: 10.1002/JPER.20-0217. Epub 2020 Sep 11.
Results Reference
background
PubMed Identifier
31456345
Citation
Seyssens L, Eghbali A, Christiaens V, De Bruyckere T, Doornewaard R, Cosyn J. A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis. Clin Implant Dent Relat Res. 2019 Oct;21(5):853-861. doi: 10.1111/cid.12843. Epub 2019 Aug 28.
Results Reference
background
PubMed Identifier
29971512
Citation
Wessels R, De Roose S, De Bruyckere T, Eghbali A, Jacquet W, De Rouck T, Cosyn J. The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery. Clin Oral Investig. 2019 Mar;23(3):1209-1215. doi: 10.1007/s00784-018-2535-6. Epub 2018 Jul 3.
Results Reference
background
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Timing of Soft Tissue Grafting Following Immediate Implant Placement
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