Peri-implantitis Management: Surgical and Maintenance Outcomes
ConditionPeri-implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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 and 2 weeks after surgery. Participants will also provide a small gum tissue sample and fluid from around the implant at baseline and about 3 months after surgery. Participants will be followed in a maintenance program for up to 5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or older.
In good general health, classified as ASA Physical Status I or II.
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.
Probing depth (PD) ≤ 5 mm
Disqualifiers
Patients with autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis) that could alter immune cell profiles independent of local peri-implant inflammation.
Chronic use of systemic corticosteroids or immunosuppressants within the past 3 months.
Uncontrolled diabetes (HbA1c > 7.5%) due to its potential impact on healing and immune response.
Active infection or antibiotic use in the 30 days prior to baseline sampling.
Trial design
Design model
Parallel
Treatments tested in this trial
Resective surgery with implantoplasty
Procedure/SurgeryIn the implantoplasty group, exposed and accessible titanium implant surfaces will be polished using a resective approach aimed at mechanically reducing macro- and micro-roughness to eliminate bacterial biofilm. No osteoplasty will be performed to avoid unnecessary soft tissue recession. Polishing will be carried out with round diamond burs (30 µm grit; diameters 1.8, 2.3, and 3.5 mm) mounted on a rotary handpiece operating at 15,000 rpm under continuous saline irrigation. The implantoplasty procedure will be standardized to approximately 5 minutes per implant.
Resective surgery with mechanical debridement
Procedure/SurgeryHard deposits will be debrided with plastic-tipped universal curettes, and all sites will be irrigated with 20 mL of sterile saline. In the control group, implant surfaces will be decontaminated using submucosal air-polishing with the Airflow Prophylaxis Master device. Copious saline irrigation will be performed prior to implant decontamination. Air-polishing will be carried out using AIR-FLOW powder PLUS, which contains erythritol (sugar alcohol, 14 µm), amorphous silica, and 0.3% chlorhexidine. The device will be set to full power with irrigation. After decontamination, surgical sites will be irrigated thoroughly with sterile saline to remove any residual granulation tissue, titanium debris, or polishing particles
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Resective surgery with implantoplastyExperimental treatment 1 intervention
Group B: Resective surgery with mechanical debridementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean change from baseline in peri-implant probing depth (millimeters)
Probing depth will be measured to the nearest 1 millimeter at 6 sites per implant (MB, B, DB, ML, L, DL) using a UNC-15 periodontal probe by a calibrated examiner.
Time frame
Baseline and 3 months post-surgerySecondary outcomes
1
Percentage of sites with bleeding on probing (percentage)
Bleeding on probing will be assessed at 6 sites per implant and summarized as the percentage of sites with bleeding.
Time frame
Baseline and 3 months post-surgery.2
Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome)
Plaque accumulation will be assessed using the Modified Plaque Index (mPI) for dental implants, a 4-point ordinal scale where 0 = no detection of plaque / no visible plaque, 1 = plaque only recognized by running a probe across the marginal surface, 2 = plaque can be seen by the naked eye (\>25%), and 3 = abundance of soft matter. Scores range from 0 (minimum, best outcome) to 3 (maximum, worst outcome). Higher scores indicate greater plaque accumulation. Results will be summarized as the mean score per implant across the 6 sites assessed.
Time frame
Baseline and 3 months post-surgery3
Modified gingival index (score)
Peri-implant mucosal inflammation will be assessed using the modified gingival index (mGI) and summarized as the mean score per implant.
Time frame
Baseline and 3 months post-surgery4
Implant mucosal index (IMI) (score on a scale, 0-4; higher score = worse outcome)
Peri-implant mucosal inflammation will be assessed using the Implant Mucosal Index, a 5-point ordinal scale based on light probing where 0 = no bleeding, 1 = minimal single-point bleeding, 2 = moderate multipoint bleeding, 3 = profuse multipoint bleeding, and 4 = suppuration. Scores range from 0 (minimum, best outcome) to 4 (maximum, worst outcome). Higher scores indicate more severe peri-implant inflammation. Results will be summarized as the worst score per implant across the 6 sites assessed.
Time frame
Baseline and 3 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov