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NCT07550127NARecruiting

Peri-implantitis Management: Surgical and Maintenance Outcomes

University of Pittsburgh

Start Date

2/16/2026

Completion Date

6/30/2029

Summary

The goal of this clinical trial is to learn how two standard surgical treatments for peri-implantitis affect inflammation around dental implants. Participants will be randomly assigned to receive resective surgery with implantoplasty or resective surgery with mechanical debridement only. Participants will provide blood samples before surgery, about 48 hours after surgery, and about 2 weeks after surgery. Participants will also provide saliva samples before surgery and about 2 weeks after surgery, and small gum tissue samples at baseline and about 3 months after surgery. Participants will attend approximately 24 visits and will be followed in a maintenance program for up to 5 years. Show more lines

Detailed Description

This is a single-site, parallel-arm randomized clinical trial in adults with peri-implantitis requiring resective surgery. Participants will be assigned to resective surgery with implantoplasty or resective surgery with mechanical debridement only. Blood will be collected at baseline (pre-surgery), 48 hours post-surgery, and 2 weeks post-surgery. Saliva will be collected at baseline and 2 weeks post-surgery. Gingival tissue biopsies will be collected at baseline and 3 months post-surgery for spatial transcriptomic and histological analyses. An additional follow-up visit will occur at approximately 2 months post-surgery for reinforcement of oral hygiene instructions. Participants will then be followed in a structured supportive care program with visits every 3 months from Month 6 through Month 60.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria To be enrolled, the participant must met the following inclusion criteria: 1. Aged 18 or older. 2. In good general health, classified as ASA Physical Status I or II. 3. Diagnosed with peri-implantitis requiring resective surgical treatment, characterized by: Bleeding on probing (BOP) around dental implants. Probing pocket depths (PPD) greater than 6 mm. Implants in function for over 1 year with progressive bone loss exceeding 3 mm. Initial screening confirmed by panoramic radiographs, cone-beam computed tomography (CBCT), and clinical diagnosis. To be enrolled in the maintenance phase, participants must meet clinical stability criteria at the time of enrollment: * Probing depth (PD) ≤ 5 mm * Bleeding on probing (BOP) ≤ 1 point * Absence of suppuration (SOP) * Absence of progressive bone loss compared to pre-treatment bone levels Exclusion Criteria: 1. Patients with autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis) that could alter immune cell profiles independent of local peri-implant inflammation. 2. Chronic use of systemic corticosteroids or immunosuppressants within the past 3 months. 3. Uncontrolled diabetes (HbA1c \> 7.5%) due to its potential impact on healing and immune response. 4. Active infection or antibiotic use in the 30 days prior to baseline sampling. 5. Pregnancy or breastfeeding. 6. Inability to undergo venipuncture or tolerate soft tissue biopsy. 7. Inability to attend the 3-month follow-up visit or comply with study protocol. 8. History of malignancy requiring systemic therapy within the past 5 years.

Interventions

PROCEDURE

Resective surgery with implantoplasty

PROCEDURE

Resective surgery with mechanical debridement

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Conditions

Peri-implantitis

Locations

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania 15213

United States