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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
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.
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States
RECRUITINGMean 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-surgery
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.
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-surgery
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-surgery
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-treatment
Mean Width of Keratinized Mucosa (millimeters)
The width of keratinized mucosa (KM) will be measured in millimeters (mm) at the mid-buccal and mid-lingual aspects of each experimental implant using a UNC-15 probe.
Time frame: Baseline and 3 months post-surgery.
Disease resolution (dichotomic)
Disease resolution will be assessed for all implants and defined as: Absence of profuse BOP, absence of suppuration, PD ≤ 5 mm and absence of progressive bone loss compared to pre-treatment bone levels.
Time frame: 3 months, 12 months
Disease recurrence (dichotomic)
Assessed on all implants, defined as presence of profuse BOP and/or suppuration, increase in PPD, and progressive MBL of \> 0.5 mm compared to the previous examination.
Time frame: 2, 3, 4, and 5 years post-surgery
Cellular Composition of Peri-implant Tissue Assessed by Spatial Transcriptomics
Peri-implant tissue samples will undergo spatial transcriptomic analysis to characterize cellular composition and compare the peri-implant tissue microenvironment between treatment groups.
Time frame: Baseline and 3 months post-surgery
Change in Serum Cytokine, Chemokine, and Growth Factor Levels
Serum samples will be analyzed using a multiplex cytokine, chemokine, and growth factor panel on the Luminex system. Each analyte concentration will be assessed separately and compared between treatment groups and across collection time points.
Time frame: Baseline, 48 hours post-surgery, and 2 weeks post-surgery
Change in Salivary Protein Biomarker Levels
Unstimulated whole saliva samples will be analyzed using multiplex protein assays. Salivary biomarker levels will be compared between treatment groups and across collection time points.
Time frame: Baseline and 2 weeks post-surgery
Titanium Particle Density in Peri-implant Tissue (particles/mm²)
Titanium particles will be identified in peri-implant tissue. Particle density will be calculated as the number of confirmed titanium particles divided by the analyzed tissue area.
Time frame: Baseline and 3 months post-surgery
Percentage of Peri-implant Tissue Area Occupied by Titanium Particles
The area occupied by confirmed titanium particles will be measured using ImageJ/Fiji and expressed as a percentage of the analyzed tissue region of interest.
Time frame: Baseline and 3 months post-surgery
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