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

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.

Study Overview

• Status: Recruiting
• Conditions: Peri Implantitis
• Intervention / Treatment: Procedure: Simultaneous peri-implant debridement and regeneration; Procedure: Staged peri-implant debridement and regeneration

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Purnima Kumar, DDS, PhD; Phone Number: 17347632105; Email: kpurnima@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan School of Dentistry
      • Contact: Purnima Kumar, BSD, MS, PhD; Phone Number: 734-763-2105; Email: kpurnima@umich.edu
      • Principal Investigator: Purnima Kumar, BDS, MS, PhD
      • Sub-Investigator: Muhammad Saleh, BDS, MSD
      • Sub-Investigator: Paolo Nava, DDS
      • Sub-Investigator: Hamoun Sabri, DMD, PgC
      • Sub-Investigator: Yousef Amrou, DDS
      • Sub-Investigator: Khushboo Kalani, DDS
      • Sub-Investigator: Tamires Dutra, DDS, MS, PhD
      • Sub-Investigator: Aster Vas, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 .

No implant mobility and no evidence of occlusal overload. In patients presenting with more than one implant meeting the inclusion criteria, a single implant will be randomly selected for inclusion in the study.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Simultaneous peri-implant debridement and regeneration; The peri-implant defect will be debrided and regenerated at the same visit.
Experimental: 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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic change	change in radiographic bone volume will be measured	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Osteology Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis; Biological Phenomena; Regeneration
• Other Study ID Numbers: HUM00235330; AWD029397 (Other Grant/Funding Number: osteology Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are several patient level variables that can be used to identify the patient when used in combination.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No