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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new method for treating gum disease around dental implants, known as peri-implantitis. Researchers compare two types of membranes used in dental surgery: a new reinforced PTFE Mesh and a collagen membrane, both placed over bone grafts to aid recovery. The goal is to determine which membrane better supports gum healing and regeneration. Individuals with at least one dental implant affected by peri-implantitis and no serious health issues may qualify for this study. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance future dental treatments.

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 prior data suggests that the PTFE Mesh Membrane and Collagen Membrane are safe for dental surgery?

Research has shown that PTFE Mesh membranes, used in surgeries such as those for gum disease around implants, are generally safe. In studies involving 560 patients who underwent these surgeries, the membranes were mostly well-tolerated. Some complications occurred, but they did not harm the patients.

Collagen membranes are also under study for these treatments. Commonly used in dental surgery, they are known to be safe and effective in aiding bone and tissue healing.

Overall, both PTFE Mesh and collagen membranes have been safely used in dental procedures. While minor issues can occur, serious problems are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these regenerative treatments for peri-implantitis because they explore innovative ways to support bone healing. Unlike the standard treatments that often rely on debridement and antiseptic solutions, these investigational approaches focus on using membranes to cover bone grafts, which can enhance regeneration. The PTFE Mesh Membrane is unique due to its reinforced structure, potentially offering more robust protection and support for the graft. On the other hand, the Collagen membrane might promote natural tissue integration due to its biological composition. By enhancing the environment for bone regeneration, these treatments could offer more effective and longer-lasting solutions for patients with peri-implantitis.

What evidence suggests that this trial's treatments could be effective for peri-implantitis?

This trial will compare the effectiveness of two different membranes for treating peri-implantitis, a type of gum disease around dental implants. Participants in one arm of the trial will receive a reinforced PTFE Mesh membrane. Research shows this membrane provides a strong barrier that may improve healing. Another arm will use a collagen membrane, which studies suggest aids bone regeneration. Research indicates that both membrane types can strengthen the bone around implants and improve gum health. ^{1 4 6 7 8}

Who Is on the Research Team?

Muhammad Saleh, BDS, MSD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295663/

Reassessing the Use of Membranes in Peri-Implantitis ... This systematic review and meta-analysis of in vivo studies aimed to evaluate the efficacy of barrier membranes in the reconstructive surgical ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023006953

Evaluation of efficacy of non-resorbable membranes ... The available evidence suggests that RES and N-RES membranes are equally effective in GBR. However, the evidence must be interpreted with caution due to its ' ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jcpe.14129

Impact of Collagen Membrane in Vertical Ridge ... To date, the effect of using perforated PTFE meshes alone on bone regeneration outcomes following VRA are yet to be established. Therefore, the ...

4. deepblue.lib.umich.edu deepblue.lib.umich.edu/bitstream/handle/2027.42/198087/Rafael%20Pereira%20Thesis.pdf?sequence=1&isAllowed=y

Regenerative treatment of peri-implantitis ... membrane and reinforced PTFE mesh (RPM), were clinically viable for the regenerative surgical treatment of peri-implantitis. However, the collagen membrane ...

5. withpower.com withpower.com/trial/phase-peri-implantitis-10-2023-acf7d

Regenerative Treatment for Peri-Implantitis 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949596/

Impact of Collagen Membrane in Vertical Ridge ... To date, the effect of using perforated PTFE meshes alone on bone regeneration outcomes following VRA are yet to be established. Therefore, the ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jre.70005

Membranes for Periodontal and Bone Regeneration This paper presents and highlights a summary of the past, present, and future of membranes for oral regeneration in clinical applications ...

8. fda.gov fda.gov/media/158495/download

Polytetrafluoroethylene (PTFE) The PSO data included 4 reports of complication with associated harm scores indicating error, but no harm to the patient. 7. The healthcare ...