Peri-Implantitis Clinical Trial
Official title:
Reconstructive Surgical Therapy of Peri-implantitis: 3-year Results of a Randomized Clinical Trial
Verified date | February 2021 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Various treatment protocols of peri-implantitis involving surgical therapies with open flap debridement procedures, resective or reconstructive modalities have been documented to achieve variable success. Surgical non-reconstructive approaches have been suggested to have limited effectiveness in terms of the resolution of inflammation in the long term. Therefore, much more interest has been intensified regarding the efficacy of biomaterials used in reconstructive approaches. The aim of this study was to investigate the 3-year clinical/radiographic outcomes of reconstructive surgical therapy of peri-implantitis using a bone substitute combined with two different bioresorbable barrier membranes, either collagen membrane (CM) or concentrated growth factor (CGF). A total of 52 patients who had at least one implant diagnosed with peri-implantitis and needed to be scheduled for reconstructive therapy of a peri-implant infrabony defect were included. Peri-implantitis case was defined as increased probing depth (PD) compared to previous examinations with bleeding on probing (BOP) and/or suppuration and radiographic evidence of peri-implant bone loss beyond crestal bone level changes resulting from initial bone remodeling. The patients were randomly assigned to receive a bone substitute filling in combination with either CM or CGF. Intrabony components were filled with a bone substitute (BioOss spongiosa granules; Geistlich, Wolhusen, Switzerland) and covered with a CM (Bio-Guide, Geistlich Biomaterials) or CGF membrane. The plaque index (PI), gingival index (GI), BOP, PD, clinical attachment level (CAL), mucosal recession (MR) and radiographic vertical defect depth (VDD) values were evaluated at 1 and 3 years postoperatively.
Status | Completed |
Enrollment | 52 |
Est. completion date | February 12, 2021 |
Est. primary completion date | February 12, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - age > 18 years, - having at least one implant demonstrating two- or three-wall infrabony defect =3 mm, which presented a probing depth of =5 mm with BOP and/or suppuration, - no implant mobility and no evidence of occlusal overload. Exclusion Criteria: - serious systemic diseases, medications or conditions that would contraindicate for periodontal surgery and compromise wound healing, - a history of taking systemic antibiotic during the past 3 months, and - placement, and prosthetic loading of implants within the past year. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University Faculty of Dentistry | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean vertical radiographic defect depth (VDD) | Radiographic vertical defect depth (VDD) was measured between the first bone-to-implant contact and the reference point at the coronal part of the implant body at both mesial and distal aspects of the implants. | Postoperative 3 years | |
Secondary | Plaque index | Silness & Löe plaque index (PI) marked with a score from 0 to 3 (0: absence of microbial plaque; 1: thin film of microbial plaque; 2: moderate accumulation with plaque in the sulcus; 3: large amount of plaque in sulcus or pocket along the free gingival margin) | Baseline, postoperative 1 and 3 years | |
Secondary | Gingival index | Löe & Silness index (GI) marked with a score from 0 to 3. (0: normal gingiva; 1: mild inflammation, 2: moderate inflammation, 3: severe inflammation) | Baseline, postoperative 1 and 3 years | |
Secondary | Bleeding on probing (percent [%]) (BOP) | BOP was assessed according to presence or absence of bleeding 30 s after gentle probing | Baseline, postoperative 1 and 3 years | |
Secondary | Probing depth (mm) (PD) | PD was measured as the distance from the mucosal margin to the bottom of the probeable pocket | Baseline, postoperative 1 and 3 years | |
Secondary | Clinical attachment level (mm) (CAL) | Clinical attachment level (CAL) defined as PD+ mucosal recession. | Baseline, postoperative 1 and 3 years | |
Secondary | Mucosal recession (mm) (MR) | Mucosal recession (MR) was measured as the distance from the mucosal margin and the implant abutment interface | Baseline, postoperative 1 and 3 years |
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