Bone Graft Surgery for Peri-Implantitis
What You Need to Know Before You Apply
What is the purpose of this trial?
The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.
Will I have to stop taking my current medications?
If you are taking corticosteroids, IV bisphosphonates, immunosuppressants, or medications with side effects of gingival growth, you may need to stop as these could affect healing. The trial does not specify a washout period, but these medications are part of the exclusion criteria.
Is bone graft surgery for peri-implantitis using InterOss Collagen safe for humans?
The studies reviewed do not provide specific safety data for InterOss Collagen in bone graft surgery for peri-implantitis, but they do suggest that using collagen membranes and bone substitutes in similar procedures is generally considered feasible and safe. However, more research is needed to confirm safety in larger groups.12345
How is the treatment InterOss Collagen unique for peri-implantitis?
InterOss Collagen is unique for treating peri-implantitis because it combines a bone graft material with collagen, which may help in both bone regeneration and soft tissue healing. This dual approach can potentially enhance the stability and success of the treatment compared to using bone grafts or collagen alone.678910
What data supports the effectiveness of the treatment InterOss Collagen, InterOss Collagen Guide for peri-implantitis?
Who Is on the Research Team?
Andrea Ravida, DDS MS PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults over 18 with peri-implantitis, who are patients at the University of Pittsburgh Periodontics Department. They must have good oral hygiene scores and be systemically healthy. Excluded are those with uncontrolled oral diseases, allergies to dental anesthetics, diabetes, certain medication histories, pregnant or lactating women, heavy smokers, and individuals with conditions affecting healing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgical
Medical history review, removal of prosthetic superstructures, and oral hygiene instructions
Surgical Treatment
Regenerative surgical procedure with randomization to control or test groups
Follow-up
Post-operative follow-up to assess healing and remove sutures
Re-entry Procedure
Re-entry procedure to assess bone levels and replace superstructures
Post-op after Stage 2
Assessment of healing and potential crown replacement
Crown Placement/Replacement
Placement or replacement of implant crown
8 Months Follow-up
Assessment of peri-implant probing depth and bleeding on probing
12 Months Follow-up
Final assessment of treatment success and radiographic measurements
What Are the Treatments Tested in This Trial?
Interventions
- InterOss Collagen
- InterOss Collagen Guide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrea Ravida
Lead Sponsor
SigmaGraft Inc.
Collaborator