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

NCT07325747 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2027-02-28
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325747 on ClinicalTrials.gov