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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

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

Qualifiers

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

Treatments tested in this trial

  • Staged peri-implant debridement and regeneration
  • Simultaneous peri-implant debridement and regeneration

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Michigan

Lead sponsor

Osteology Foundation

Collaborator