Bone Graft Surgery for Peri-Implantitis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Andrea Ravida

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

I am generally healthy aside from my current condition.

Patients of record at the University of Pittsburgh Periodontics Department

Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at six sites per tooth)

Exclusion Criteria

I do not have untreated cancer or gum disease in my mouth.

I am not on medications that affect healing or bone integration.

I have had chemotherapy or radiation for head or neck cancer within the last 5 years.

Treatment Details

Interventions

• InterOss Collagen (Bone Substitute)
• InterOss Collagen Guide (Collagen Membrane)

Trial Overview The study compares two surgical treatments for peri-implantitis: one using a bone graft alone (InterOss Collagen), and another combining the bone graft with a resorbable collagen membrane (InterOss Collagen Guide). The goal is to see which method better improves bone defects around dental implants.

Participant Groups

Group I: Bone grafting with collagen membrane Experimental Treatment 1 Intervention

This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft.

Group II: Bone grafting without collagen membrane Active Control 1 Intervention

This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft.

Who Is Running the Clinical Trial?

Andrea Ravida

Lead Sponsor

Trials

2

Recruited

140+

SigmaGraft Inc.

Collaborator

Trials

1

Recruited

50+