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Peri-implantitis Management: Surgical and Maintenance Outcomes

Sponsor: University of Pittsburgh • ClinicalTrials.gov ID: NCT07550127

Registry updated: 2026-09-10

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Description

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

Interventions

Resective surgery with implantoplasty (Procedure)
In the implantoplasty group, exposed implant surfaces not covered by bone will be mechanically smoothed using a resective approach aimed at reducing surface roughness. No osteoplasty will be performed. Implantoplasty will be carried out using oval-shaped tungsten carbide burs of progressively increasing diameter mounted on a rotary handpiece. Surface refinement will then be completed using white Arkansas stone burs, followed by polishing with brown and green silica polishing burs under copious saline irrigation. The implantoplasty procedure will be standardized to approximately 5 minutes per implant.
Resective surgery with mechanical debridement (Procedure)
In the mechanical debridement group, visible calculus will be removed using an ultrasonic tip without direct contact with the implant surface. Implant surfaces will then be decontaminated using the Airflow Prophylaxis Master device with erythritol (14 μm), amorphous silica, and 0.3% chlorhexidine. The device will be operated at a static pressure of 5 bar with maximal water irrigation. No implantoplasty will be performed.

Eligibility criteria

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.

Conditions

Peri-implantitis

Locations

University of Pittsburgh School of Dental Medicine — Pittsburgh, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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