Bone Graft Surgery for Peri-Implantitis

Overseen By Martinna Bertolini, PhD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrea Ravida

Must not be taking: Corticosteroids, IV bisphosphonates, immunosuppressants

Disqualifiers: Cancer, Active periodontal disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment InterOss Collagen, InterOss Collagen Guide for peri-implantitis?

The research suggests that regenerative surgical treatments, which may include bone substitutes like InterOss Collagen, can be effective in treating peri-implantitis, as they help in bone regeneration and improving clinical outcomes over time. ^{11 12 13 14 15}

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1.5 hours

1 visit (in-person)

Pre-surgical

Medical history review, removal of prosthetic superstructures, and oral hygiene instructions

2 hours

1 visit (in-person)

Surgical Treatment

Regenerative surgical procedure with randomization to control or test groups

4-6 weeks after pre-surgical phase

1 visit (in-person)

Follow-up

Post-operative follow-up to assess healing and remove sutures

4 weeks

1 visit (in-person)

Re-entry Procedure

Re-entry procedure to assess bone levels and replace superstructures

4 months

1 visit (in-person)

Post-op after Stage 2

Assessment of healing and potential crown replacement

2 weeks after re-entry

1 visit (in-person)

Crown Placement/Replacement

Placement or replacement of implant crown

1 month after post-op

1 visit (in-person)

8 Months Follow-up

Assessment of peri-implant probing depth and bleeding on probing

8 months post-op

1 visit (in-person)

12 Months Follow-up

Final assessment of treatment success and radiographic measurements

12 months post-op

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• InterOss Collagen
• InterOss Collagen Guide

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.

How Is the Trial Designed?

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+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The Impact of Implantoplasty in Regenerated and Nonregenerated Treatment Modalities in Peri-implantitis: A Systematic Review and Meta-analysis. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes of a combined resective and regenerative approach in the treatment of peri-implantitis: a prospective case series. [2016]

3. Denmark pubmed.ncbi.nlm.nih.gov

Long-term outcome of surgical treatment of peri-implantitis. A 2-11-year retrospective study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The effect of reconstructive techniques as treatment modality for peri-implant osseous defects - a systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Effect of collagen membrane and of bone substitute on lateral bone augmentation with titanium mesh: An experimental in vivo study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Regenerative Surgery by Peri-implant Excision and Regenerative Surgery (PERS) in Peri-implantitis: One-year Result on Three Cases. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Interproximal implant thread exposure after initial bone remodeling as a risk indicator for peri-implantitis. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Wound dehiscences following pre-implant bone augmentation with autogenous iliac crest bone grafts: A retrospective cohort study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Regenerative treatment of peri-implantitis using bone substitutes and membrane: a systematic review. [2019]

12. India pubmed.ncbi.nlm.nih.gov

Efficacy of implantoplasty in management of peri-implantitis: A systematic review. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Combined surgical resective and regenerative therapy for advanced peri-implantitis with concomitant soft tissue volume augmentation: a case report. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. [2016]

15. Denmark pubmed.ncbi.nlm.nih.gov

Reconstructive treatment of peri-implantitis infrabony defects of various configurations: 5-year survival and success. [2022]