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 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.
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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 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/SurgeryIn 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.
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 sulcus bleeding index (score)
Peri-implant mucosal inflammation will be assessed using the modified sulcus bleeding index (mSBI) and summarized as the mean score per implant.
Time frame
Baseline and 3 months post-surgery4
Marginal bone loss (millimeters)
Marginal bone level will be measured on standardized periapical radiographs as the distance from the implant platform to the first bone-to-implant contact at mesial and distal sites at both baseline and 3 months follow-up. Marginal bone loss will be determined as the difference between both timepoints.
Time frame
Baseline and 3 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov