Surgical Reconstruction for Peri-Implantitis
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical reconstruction of peri-implantitis intra-bony defects in terms of the clinical, radiographical, histological, volumetric, microbiological, and patient-reported outcomes.
The investigators hypothesize that in certain clinical situations, treatment of peri-implantitis intra-bony defects with the use of a compound bone grafting material (mixture of allogenic bone substitutes) and a non-resorbable barrier membrane and following a delayed approach (test group) with initial phase of defect decontamination and initial healing phase would yield superior outcomes to that of the conventional approach (control group) of defect decontamination and regeneration at the same clinical visit while also significantly enhancing patient-reported outcomes:
H0: There is no difference between the two mentioned approaches in terms of the treatment outcomes. H1: There is a significant difference, favoring the delayed approach compared to the immediate reconstruction.
Are 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
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