Actively Recruiting
Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects.
Led by University of Michigan · Updated on 2026-02-06
40
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
O
Osteology Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical reconstruction of peri-implantitis intra-bony defects in terms of the clinical, radiographical, histological, volumetric, microbiological, and patient-reported outcomes. The investigators hypothesize that in certain clinical situations, treatment of peri-implantitis intra-bony defects with the use of a compound bone grafting material (mixture of allogenic bone substitutes) and a non-resorbable barrier membrane and following a delayed approach (test group) with initial phase of defect decontamination and initial healing phase would yield superior outcomes to that of the conventional approach (control group) of defect decontamination and regeneration at the same clinical visit while also significantly enhancing patient-reported outcomes: H0: There is no difference between the two mentioned approaches in terms of the treatment outcomes. H1: There is a significant difference, favoring the delayed approach compared to the immediate reconstruction.
CONDITIONS
Official Title
Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy adults
- Age 60 18 years
- Able to perform good oral hygiene
- Have at least one implant with cement or screw-retained prosthesis showing peri-implantitis and in function for at least 1 year
- Presence of bleeding and/or suppuration on gentle probing, increased probing depth compared to previous exams, and radiographic evidence of bone loss beyond initial remodeling if prior radiographs are available
- If no prior radiographs, presence of probing pocket depth 60 6 mm with bleeding and/or suppuration and marginal bone loss over 3 mm on implant in function for at least 1 year
- Target implants must have intra-bony defect with depth 60 3 mm and width 604 mm, with minimum two walls, confirmed radiographically and intra-surgically
- No implant mobility or occlusal overload
- If multiple implants qualify, one implant will be randomly selected
You will not qualify if you...
- Short implants (6 mm or less)
- Contraindications for oral surgery
- Pregnant, attempting pregnancy, or nursing
- Untreated or active periodontitis or acute infections at surgical site
- Untreated malignancies at surgical site
- Current smoking, tobacco chewing, or chronic vaping
- Taking long-term NSAIDs, prednisone, or anti-inflammatory drugs for over 1 year
- History of blood disorders such as abnormal thrombin or factor XIII levels, or hemophilia
- Significant co-morbidities including obesity, uncontrolled diabetes, immunosuppression, severe bone diseases, malnutrition, immunosuppressive therapy, poor tissue oxygenation or perfusion, or radiation therapy
- Unable to give consent for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
P
Purnima Kumar, DDS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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