About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Systemically healthy adults
Age ≥ 18 years
The patient must be able to perform good oral hygiene
With at least one implant with either cement or a screw-retained prosthesis demonstrating a diagnosis of peri-implantitis at an implant in function for a minimum of 1 year with a prosthesis installed.
Disqualifiers
Short implants (≤ 6mm)
Contraindications for undergoing oral surgery.
Patients pregnant or attempting to get pregnant (self-reported), or nursing women.
Untreated/active periodontitis, or other untreated acute infections at the surgical site.
Trial design
Parallel
Treatments tested in this trial
Staged peri-implant debridement and regeneration
Procedure/SurgeryPeri-implant debridement will be carried our in visit one and will be followed by a second surgery for regeneration
Simultaneous peri-implant debridement and regeneration
Procedure/SurgeryThe peri-implant defect will be debrided and regenerated at the same visit.
Treatment groups
Trial outcomes
Primary outcomes
Radiographic change
change in radiographic bone volume will be measured
Sponsors and contacts
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University of Michigan
Lead sponsor
Osteology Foundation
Collaborator