Regenerative Treatment for Peri-Implantitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Bisphosphonates, Corticosteroids, others

Disqualifiers: Uncontrolled diabetes, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 months

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect bone metabolism or wound healing, like bisphosphonates or corticosteroids. If you're on such medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Membrane placement with bone grafting for peri-implantitis?

Research shows that using bone grafts and membranes can help fill bone defects and improve stability in the treatment of peri-implantitis, as seen in studies evaluating long-term outcomes and systematic reviews of similar treatments. ^{1 2 3 4 5}

Is the regenerative treatment for peri-implantitis using bone grafts and membranes safe for humans?

The studies suggest that using bone grafts and membranes for treating peri-implantitis is generally safe, with improvements in bone stability and reduced inflammation over time. Patients in these studies showed stable conditions and reduced signs of inflammation after treatment. ^{1 2 6 7 8}

How is the membrane placement with bone grafting treatment for peri-implantitis different from other treatments?

This treatment is unique because it combines a membrane with bone grafting to regenerate bone around dental implants affected by peri-implantitis. Unlike some other treatments, it uses a guided bone regeneration approach, which involves placing a barrier membrane to protect the bone graft and promote new bone growth, although there is a risk of early membrane exposure and infection. ^{1 2 9 10 11}

What is the purpose of this trial?

The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.

Research Team

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults over 18 with healthy or moderately controlled systemic diseases, who have dental implants affected by peri-implantitis but not severely mispositioned or mobile. Participants should not be heavy smokers, pregnant, taking certain bone-affecting drugs, or have uncontrolled diabetes.

Inclusion Criteria

I have a dental implant with gum issues around it, following the 2017 guidelines.

I am generally healthy or have mild to moderate health issues that are well-controlled.

Exclusion Criteria

Significant interproximal horizontal bone loss (more than 50% of implant fixture length)

Pregnant subjects or individuals attempting to get pregnant (self-reported)

I am not on medications that affect bone healing or have uncontrolled health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical reconstructive treatment of peri-implantitis using either a reinforced PTFE Mesh membrane or a collagen membrane

8 months

1 visit (surgery)

Follow-up

Participants are monitored for clinical attachment levels, bone measurements, and volumetric changes of grafted area

8 months

Multiple visits for assessments

Treatment Details

Interventions

• Membrane placement with bone grafting

Trial Overview The study compares two surgical treatments for gum disease around dental implants: a new d-PTFE membrane called RPM and the traditional collagen membrane to see which one better supports bone regeneration.

Participant Groups

Group I: PTFE Mesh Membrane Experimental Treatment 1 Intervention

A reinforced PTFE Mesh membrane will be used to cover the bone graft.

Group II: Collagen membrane Active Control 1 Intervention

A collagen membrane will be used to cover the bone graft.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Osteogenics Biomedical

Industry Sponsor

Trials

5

Recruited

190+

References

1. 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]

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

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

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

Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. [2022]

4. 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]

5. 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]

6. Brazil pubmed.ncbi.nlm.nih.gov

A prospective case series on surgical treatment of circumferential and semi-circumferential defects due to peri-implantitis. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

Effect of membrane exposure on guided bone regeneration: A systematic review and meta-analysis. [2018]

8. Denmark pubmed.ncbi.nlm.nih.gov

Influence of two barrier membranes on staged guided bone regeneration and osseointegration of titanium implants in dogs: part 1. Augmentation using bone graft substitutes and autogenous bone. [2018]

9. Poland pubmed.ncbi.nlm.nih.gov

Bone graft substitutes in periodontal and peri-implant bone regeneration. [2006]

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

A single-centre randomized controlled clinical trial on the adjunct treatment of intra-bony defects with autogenous bone or a xenograft: results after 12 months. [2022]

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

Treatment of peri-implant defects with the vertical ridge augmentation procedure: a patient report. [2013]