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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two surgical methods for treating peri-implantitis, a condition where inflammation and damage occur around dental implants. Researchers aim to determine whether adding a collagen membrane (InterOss Collagen Guide) over a bone graft (InterOss Collagen) improves outcomes compared to using the bone graft alone. Participants should have a dental implant showing signs of damage, such as deep pockets and bone loss. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future dental treatments.

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.

What prior data suggests that these surgical methods are safe for treating peri-implantitis?

Research has shown that InterOss Collagen is generally well-tolerated. In studies, patients experienced positive results with few side effects when using this bone graft material. Surgeons have successfully used it to address bone issues caused by peri-implantitis, which involves inflammation around dental implants.

One study found no major negative effects linked to InterOss Collagen, suggesting it is safe for most people. Using it with a collagen membrane does not significantly alter its safety.

InterOss Collagen is a bone graft substitute, and similar products have been reviewed and approved by health authorities like the FDA for other uses. This background supports its safety in treating peri-implantitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of InterOss Collagen in treating peri-implantitis because it offers a novel approach by incorporating a bone xenograft substitute that could enhance bone regeneration. Unlike the standard treatment options, which often involve mechanical debridement and antibiotic therapy, this method introduces a collagen membrane (InterCollagen Guide) that may further support bone healing and integration around dental implants. The potential for improved bone regeneration and support around implants could lead to better long-term outcomes for patients suffering from peri-implantitis.

What evidence suggests that these surgical methods could be effective for treating peri-implantitis?

Research shows that InterOss Collagen is a promising material for bone grafts in dental surgeries, including those treating inflammation around dental implants. Studies have found that InterOss Collagen has a large surface area and is very porous, both important for bone growth and healing. In this trial, one group will receive InterOss Collagen with a collagen membrane, which may protect the graft and improve results. This combination could enhance bone healing and lower the risk of implant failure. Another group will receive InterOss Collagen without the collagen membrane. Early results from similar treatments suggest these approaches might effectively support bone regrowth and maintain implant stability. ^{6 7 8 9 10}

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 am not on medications that affect healing or bone integration.

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

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05699343?locStr=United+States&country=United+States&aggFilters=status%3A

Surgical Treatment of Peri-implantitis Using a Bone Substitute ... The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8951741/

A Comparative Study of Two Bone Graft Substitutes ... We found two bone graft substitutes to be mostly similar, though InterOss Collagen showed comparatively higher surface area and porosity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12529224/

Peri‐Implantitis and Survival Outcomes of Tissue Level Versus ... Outcomes: Peri‐implantitis rate, changes in marginal bone level, changes in probing pocket depth, and implant failure rate. Study design: ...

4. link.springer.com link.springer.com/article/10.1007/s40496-024-00381-4

Peri-Implant Wound Healing and Clinical Outcomes This review provides an in-depth evaluation of the existing information on peri-implant wound healing basics with a specific focus on local and systemic ...

5. researchgate.net researchgate.net/publication/359124639_A_Comparative_Study_of_Two_Bone_Graft_Substitutes-InterOss_Collagen_and_OCS-B_Collagen

(PDF) A Comparative Study of Two Bone Graft Substitutes ... Based on these results, InterOss Collagen is a promising dental bone grafting material for periodontal and maxillofacial surgeries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7536094/

Peri-implantitis Update: Risk Indicators, Diagnosis, and ... The identified risk indicators of peri-implant diseases are plaque, smoking, history of periodontitis, surface roughness, residual cement, emergence angle >30 ...

7. mdpi.com mdpi.com/2077-0383/13/16/4638

Evaluation of Peri-Implantitis Bone Defect Healing Peri-implantitis is a serious inflammation of the tissues around dental implants that can lead to implant loss and systemic health problems if ...

8. clinicaltrial.be clinicaltrial.be/en/details/189756?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Surgical Treatment of Peri-implantitis Using a Bone Subst... The purpose of the study is to compare treatment outcomes of peri-implantitis defects when using a defect fill substitute (InterOss ...

9. journals.lww.com journals.lww.com/njms/fulltext/2020/11010/risks_and_complications_associated_with_dental.4.aspx

Risks and complications associated with dental implant... This article summarizes the factors causing implant failure. This paper presents the results of a survey of dentists practicing implant dentistry and ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221808.pdf

SigmaGraft Inc. Dave Kim Medical Device Regulatory Affairs ... The objective of this study was to evaluate the in vivo performance, local effects following implantation, and systemic toxicity of the test ...