Back to resultsSA Versus SOI Surfaces for Single Implant-supported Crown
Primary Purpose
Dental Implant Failed, Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Placement of dental implants (surgical procedure)
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant Failed focused on measuring Dental implants, Implant surfaces, Marginal bone loss
Eligibility Criteria
Inclusion Criteria:
- Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Exclusion Criteria:
- Patients unable to commit to 5 years follow-up.
- General contraindications to implant surgery.
- Less then 4 mm of keratinised gingiva crestally (at the implant sites).
- Immune-suppressed/compromised patients.
- Patients irradiated in the head and/or neck.
- Uncontrolled diabetes.
- Pregnancy or lactation.
- Untreated periodontal disease.
- Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
- Addiction to alcohol or drugs.
- Psychiatric problems and/or unrealistic expectations.
- Patients with an acute infection or suppuration in the site intended for implant placement.
- Patients needing any form of tissue augmentation at implant placement.
- Immediate post-extractive implants (implants can be placed after a 3-month healing period).
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
- Patients participating in other studies, if the present protocol could not be fully adhered to.
Sites / Locations
- Erta XhanariRecruiting
- Elitsa DeliverskaRecruiting
- Fulvio GattiRecruiting
- Studio Odontoiatrico Marco TallaricoRecruiting
- Leonardo MuzziRecruiting
- Łukasz ZadrożnyRecruiting
- Cesaltino RemediosRecruiting
- MirceaRecruiting
- Andre de WaalRecruiting
- Nicolas WidmerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SA Implants
SOI Implants
Arm Description
Dental implant with sandblasted and Acid-etched (SA) surface
Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent
Outcomes
Primary Outcome Measures
Implant failure
Implant removal for any reason will be considered an implant failure.
Crown failure
Crown replacement for any reason will be considered a crown failure.
Complications
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
Secondary Outcome Measures
Peri-implant marginal bone level (MBL) changes
It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.
Probing pocket depth (PPD)
Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
Bleeding on probing (BOP)
Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
plaque index (PI)
Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant.
Implant stability quotient
The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100.
Pink Esthetic Score
The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04073654
Brief Title
SA Versus SOI Surfaces for Single Implant-supported Crown
Official Title
Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osstem AIC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
Detailed Description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Bone Resorption
Keywords
Dental implants, Implant surfaces, Marginal bone loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, split-mouth design
Masking
ParticipantOutcomes Assessor
Masking Description
Implants have same macro design.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SA Implants
Arm Type
Active Comparator
Arm Description
Dental implant with sandblasted and Acid-etched (SA) surface
Arm Title
SOI Implants
Arm Type
Experimental
Arm Description
Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent
Intervention Type
Procedure
Intervention Name(s)
Placement of dental implants (surgical procedure)
Intervention Description
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
Primary Outcome Measure Information:
Title
Implant failure
Description
Implant removal for any reason will be considered an implant failure.
Time Frame
From implant placement up to 60 months after loading
Title
Crown failure
Description
Crown replacement for any reason will be considered a crown failure.
Time Frame
From crown delivery up to 60 months
Title
Complications
Description
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
Time Frame
From implant placement up to 60 months after loading
Secondary Outcome Measure Information:
Title
Peri-implant marginal bone level (MBL) changes
Description
It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.
Time Frame
From implant placement up to 60 months after loading
Title
Probing pocket depth (PPD)
Description
Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
Time Frame
From crown delivery up to 60 months
Title
Bleeding on probing (BOP)
Description
Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
Time Frame
From crown delivery up to 60 months
Title
plaque index (PI)
Description
Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant.
Time Frame
From implant placement up to 60 months after loading
Title
Implant stability quotient
Description
The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100.
Time Frame
The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.
Title
Pink Esthetic Score
Description
The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist.
Time Frame
From crown delivery up to 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Exclusion Criteria:
Patients unable to commit to 5 years follow-up.
General contraindications to implant surgery.
Less then 4 mm of keratinised gingiva crestally (at the implant sites).
Immune-suppressed/compromised patients.
Patients irradiated in the head and/or neck.
Uncontrolled diabetes.
Pregnancy or lactation.
Untreated periodontal disease.
Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
Addiction to alcohol or drugs.
Psychiatric problems and/or unrealistic expectations.
Patients with an acute infection or suppuration in the site intended for implant placement.
Patients needing any form of tissue augmentation at implant placement.
Immediate post-extractive implants (implants can be placed after a 3-month healing period).
Patients treated or under treatment with intravenous amino-bisphosphonates.
Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
Patients participating in other studies, if the present protocol could not be fully adhered to.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Tallarico
Phone
+3280758769
Email
me@studiomarcotallarico.it
Facility Information:
Facility Name
Erta Xhanari
City
Tirana
Country
Albania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erta Xhanari
Email
info@ertaxhanari.com
Facility Name
Elitsa Deliverska
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elitsa Deliverska
Email
elitsadeliverska@yahoo.com
Facility Name
Fulvio Gatti
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulvio Gatti, Dr
Phone
+39 339 6441920
Email
fudy@libero.it
Facility Name
Studio Odontoiatrico Marco Tallarico
City
Rome
ZIP/Postal Code
00151
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Tallarico, Dr
Phone
+39 066630646
Email
me@studiomarcotallarico.it
First Name & Middle Initial & Last Name & Degree
Marco Tallarico, Dr.
Facility Name
Leonardo Muzzi
City
Siena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Muzzi
Email
leo@leomuzzi.com
Facility Name
Łukasz Zadrożny
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Łukasz Zadrożny
Email
lukasz.zadrozny@gmail.com
Facility Name
Cesaltino Remedios
City
Fatima
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesaltino Remedios
Email
cesaltinoremedios@gmail.com
Facility Name
Mircea
City
Craiova
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mircea Gheorghita
Email
gheorghitamircea@gmail.com
Facility Name
Andre de Waal
City
South Africa
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre de Waal
Email
andre@adewaal.com
Facility Name
Nicolas Widmer
City
Bern
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Widmer
Email
nicolas.widmer@gmail.com
12. IPD Sharing Statement
Learn more about this trial
SA Versus SOI Surfaces for Single Implant-supported Crown
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