Surgical Reconstruction for Peri-Implantitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two surgical methods to treat peri-implantitis, a gum disease affecting dental implants that can cause bone loss. One method, simultaneous peri-implant debridement and regeneration, addresses the issue immediately. The other, staged peri-implant debridement and regeneration, delays completion of the surgery by a few weeks. Researchers aim to determine which method results in better recovery and patient satisfaction. Suitable candidates for this trial are generally healthy individuals who have had a dental implant with peri-implantitis for at least a year. As an unphased trial, this study allows patients to contribute to valuable research that could enhance future treatment options for peri-implantitis.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes people taking long-term anti-inflammatory drugs like NSAIDs or prednisone. If you're on these medications, you might not be eligible to participate.
What prior data suggests that these surgical approaches are safe for treating peri-implantitis?
Research has shown that treatments for peri-implantitis, an infection around dental implants, using guided bone regeneration (GBR) are generally well-tolerated. In one study, 97.9% of treated implants had successful outcomes, suggesting the procedure is safe for most patients.
For the simultaneous approach, a study found that 88.6% of implants remained in place after treatment, indicating a positive safety profile overall, despite some patients experiencing a recurrence of the infection.
In the staged approach, studies have not reported any major safety concerns or side effects. This method, which involves removing dead or infected tissue and then rebuilding bone, appears to be a safe option for treating peri-implant issues.
Both methods focus on cleaning and rebuilding bone around implants, and research supports their safety. However, individual experiences can vary, so potential participants should discuss any concerns with their healthcare providers.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for peri-implantitis because they explore innovative surgical approaches to handle the condition. The simultaneous and staged peri-implant debridement and regeneration techniques aim to improve bone regeneration through immediate guided bone regeneration (GBR), offering a potentially more effective way to address the bone loss associated with peri-implantitis. Unlike standard treatments that often involve cleaning and antibiotics, these methods focus on enhancing bone repair and stability around dental implants. By exploring both immediate and staged approaches, the trial could reveal more effective strategies for managing and reversing the damage caused by peri-implantitis.
What evidence suggests that this trial's surgical approaches could be effective for peri-implantitis?
Research shows that treating peri-implantitis, inflammation around dental implants, can be challenging. In this trial, participants in the Control Group will receive simultaneous peri-implant debridement and regeneration, cleaning and repairing the area in one procedure. Studies have found that this method can lead to long-term success in about 60% of cases with ongoing care, although around 70% of these cases might still experience bone loss over time.
Participants in the Test Group will undergo a staged approach, where cleaning occurs first and rebuilding happens 4-6 weeks later. This method allows for some initial healing before rebuilding, which might improve patient satisfaction and treatment success. While more research is needed to confirm if this method is superior, early signs suggest it could lead to better outcomes in some cases.12346Are You a Good Fit for This Trial?
This trial is for systemically healthy adults over 18 who can maintain good oral hygiene. They must have at least one dental implant in function for a year with peri-implantitis, evidenced by bone loss and bleeding or suppuration upon probing. The affected implant should show an intra-bony defect of specific dimensions without mobility or occlusal overload.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Surgical removal of peri-implant granulation tissue and pocket epithelium
Healing Phase
Initial healing phase before further surgical intervention
Surgical Reconstruction
Surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via guided bone regeneration (GBR)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Simultaneous peri-implant debridement and regeneration
- Staged peri-implant debridement and regeneration
Trial Overview
The study compares two surgical methods to rebuild bone around implants with peri-implantitis: immediate debridement and regeneration versus delayed reconstruction after initial healing. It will assess clinical, radiographic, histological, volumetric, microbiological outcomes and patient satisfaction.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The subjects will receive a two-stage treatment consisting of the surgical removal of peri-implant granulation tissue and pocket epithelium. After 4-6 weeks, they will undergo surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).
The subjects will receive treatment consisting of surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Osteology Foundation
Collaborator
Citations
Immediate Versus Delayed Surgical Reconstruction of Peri ...
The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical ...
Long‐Term Treatment Outcomes of Peri‐Implantitis ...
From year 5 to 7, treatment success was recorded in 23.1% (n = 6) of CGF and 30.8% (n = 8) of CM patients, with disease recurrence in 34.6% (n = ...
Long‐term surgical treatment outcomes of peri‐implantitis
Data suggest that the long-term disease resolution is ∼60% under supportive peri-implant care, while ∼70% exhibit progressive bone loss ...
Simultaneous peri-implant debridement and regeneration and ...
The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical ...
Treatment of advanced peri-implantitis with regenerative therapy
This article reviews a regenerative technique for treatment of implants with Advanced Peri-implantitis (where bone loss is greater than 50% of the implant ...
Peri-Implantitis Regenerative Therapy: A Review
The histologic analysis confirmed that smooth implants consistently showed better results with higher bone levels regardless of the regeneration technique.
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