RecruitingNot ApplicableNCT07325747

Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects.

Immediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects: A Parallel-arm, Assessor-blind, Randomized, Controlled Clinical Trial


Sponsor

University of Michigan

Enrollment

40 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Simultaneous peri-implant debridement and regeneration and a procedure called Staged peri-implant debridement and regeneration for people with peri-implantitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStaged peri-implant debridement and regeneration

Peri-implant debridement will be carried our in visit one and will be followed by a second surgery for regeneration

PROCEDURESimultaneous peri-implant debridement and regeneration

The peri-implant defect will be debrided and regenerated at the same visit.


Locations(1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

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NCT07325747


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