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

NCT ID: NCT07325747

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-12
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

The subjects will receive treatment consisting of surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).

Group Type: ACTIVE_COMPARATOR

Simultaneous peri-implant debridement and regeneration

Intervention Type: PROCEDURE

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

Test Group

The subjects will receive a two-stage treatment consisting of the surgical removal of peri-implant granulation tissue and pocket epithelium. After 4-6 weeks, they will undergo surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR).

Group Type: EXPERIMENTAL

Staged peri-implant debridement and regeneration

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Simultaneous peri-implant debridement and regeneration

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• In cases where previous radiographic records are available: presence of bleeding and/or suppuration on gentle probing, increased probing depth compared to previous examinations, and radiographic evidence of bone loss beyond initial crestal remodeling. (Berglundh 2018).
• In cases where baseline radiographs are not available: presence of PPD ≥6 mm with BOP and/or suppuration (SUP) and radiographically detectable marginal bone loss (MBL) exceeding 3 mm on an implant in function forfor at least 1 year (Berglundh 2018).
• Target implants have to also demonstrate the presence of a peri-implant intra-bony defect with a depth ≥3 mm and width ≤4 mm, as assessed on radiographs and confirmed intra-surgically. In addition, the bony defect should present with a minimum of two walls .

Exclusion Criteria

• 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.
• Untreated malignancies at the surgical site.
• Self-reported current smoking, or active tobacco chewing, or chronic vaping.
• Taking long-term (>1yr) NSAID, prednisone or other anti-inflammatory prescription drugs
• Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia.
• Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation.
• Unable to give consent for participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osteology Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Purnima S. Kumar

Professor and Chair of the Department of Periodontics and Oral Medicine, School of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Purnima Kumar, DDS, PhD

Role: CONTACT

kpurnima@umich.edu

17347632105

Facility Contacts

Purnima Kumar, BSD, MS, PhD

Role: primary

kpurnima@umich.edu

734-763-2105

Other Identifiers

AWD029397

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00235330

Identifier Type: -

Identifier Source: org_study_id