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.
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. Gingival tissue biopsy and peri-implant crevicular fluid (PICF) will be collected at baseline and 3 months post-surgery. Participants will then be followed in a structured supportive care program with visits every 3 months from month 6 to month 60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
In 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.
Hard 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
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 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-surgery
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-surgery
Mean change from baseline in marginal bone level (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; values will be averaged.
Time frame: Baseline and 3 months post-treatment
Mean width of keratinized mucosa
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.
Elastase activity in peri-implant crevicular fluid
Elastase activity will be quantified in PICF using a fluorogenic substrate assay and reported per collected sample.
Time frame: Baseline and 3 months post-surgery
Alpha-2-macroglobulin level in peri-implant crevicular fluid
Alpha-2-macroglobulin will be measured in PICF by ELISA and reported per collected sample.
Time frame: Baseline and 3 months post-surgery
Alkaline phosphatase activity in peri-implant crevicular fluid
Alkaline phosphatase activity will be measured in PICF using p-nitrophenyl phosphate as substrate and reported per collected sample.
Time frame: Baseline and 3 months post-surgery
Interleukin-1 beta level in peri-implant crevicular fluid
Interleukin-1 beta will be measured in PICF using a multiplex immunoassay and reported per collected sample.
Time frame: Baseline and 3 months post-surgery
Bray-Curtis dissimilarity of submucosal plaque microbial communities
Microbial community differences will be summarized using Bray-Curtis dissimilarity calculated from 16S rRNA sequencing profiles.
Time frame: 3 months post surgery
Systemic immune clonal overlap frequency
The frequency of overlapping immune cell clones will be assessed by comparing single-cell RNA sequencing profiles from peripheral blood and gingival tissue biopsies.
Time frame: Baseline and 2 weeks post-surgery.
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