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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Staged peri-implant debridement and regeneration

    Procedure/Surgery

    Peri-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/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Test GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic change

change in radiographic bone volume will be measured

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Michigan

Lead sponsor

Osteology Foundation

Collaborator