Two surgical treatments for peri-implantitis: implantoplasty versus mechanical debridement
Impact of Implantoplasty on Local and Systemic Inflammation in Peri-implantitis: A Randomized Controlled Trial
This tests whether adding implantoplasty to resective surgery reduces inflammation and improves outcomes around dental implants in adults with peri-implantitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07550127 on ClinicalTrials.gov |
What this trial studies
This single-site, parallel-arm randomized trial enrolls adults with peri-implantitis requiring resective surgery and randomly assigns them to resective surgery with implantoplasty or resective surgery with mechanical debridement only. Blood is collected before surgery, about 48 hours after, and at 2 weeks, and gingival tissue and peri-implant crevicular fluid are sampled at baseline and about 3 months for molecular and inflammatory analyses. Participants then enter a structured maintenance program with visits every three months from month 6 through month 60 to monitor clinical stability and implant health. Clinical outcomes and molecular markers will be compared between groups to see if one surgical approach yields lower inflammation and better long-term stability.
Who should consider this trial
Good fit: Adults 18 or older in good general health (ASA I–II) with peri-implantitis requiring resective surgery — typically probing depths >6 mm, implants in function >1 year, and progressive bone loss >3 mm — are ideal candidates.
Not a fit: Patients with autoimmune or systemic inflammatory diseases or those unable to undergo surgery or commit to long-term follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding implantoplasty could reduce peri-implant inflammation and improve long-term implant stability, potentially lowering the need for further surgery.
How similar studies have performed: Implantoplasty has clinical precedent and some non-randomized studies report reduced disease progression, but randomized trials with long-term maintenance and molecular sampling are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh School of Dental Medicine — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Ravida, DDS, MS, PhD — University of Pittsburgh, Department of Periodontics and Oral Medicine.
- Study coordinator: Andrea Ravida, DDS, MS, PhD
- Email: andrearavida@pitt.edu
- Phone: 7347309678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.