NCT07325747

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peri Implantitis

Interventions

Type	Name	Description
PROCEDURE	Staged 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
PROCEDURE	Simultaneous peri-implant debridement and regeneration	The peri-implant defect will be debrided and regenerated at the same visit.

Timeline

• Start date: 2026-01-12
• Primary completion: 2027-02-01
• Completion: 2028-12-01
• First posted: 2026-01-08
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States