Impact of Implantoplasty on Local and Systemic Inflammation in Peri-implantitis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in peri-implant probing depth (millimeters)
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be enrolled the participant must met the following inclusion criteria:
- •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.
- •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
- •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.
- •Pregnancy or breastfeeding.
- •Inability to undergo venipuncture or tolerate soft tissue biopsy.
- •Inability to attend the 3-month follow-up visit or comply with study protocol.
- •History of malignancy requiring systemic therapy within the past 5 years.
Arms & Interventions
Resective surgery with implantoplasty
Full thickness mucoperiosteal flaps will be elevated, and granulation tissue will be removed using surgical curettes. Hard deposits will be debrided with plastic-tipped universal curettes, and all sites will be irrigated with 20 mL of sterile saline. Exposed and accessible titanium implant surfaces will be polished to reduce macro- and micro-roughness and eliminate bacterial biofilm. No osteoplasty will be performed. Polishing will be carried out with round diamond burs (30 µm grit; diameters 1.8, 2.3, and 3.5 mm) at 15,000 rpm under continuous saline irrigation, standardized to ~5 minutes per implant. Surgical sites will be irrigated thoroughly with sterile saline to eliminate remaining granulation tissue, titanium debris, or polishing particles. Flaps will then be repositioned and secured using single interrupted sutures to allow for optimal healing.
Intervention: Resective surgery with implantoplasty (Procedure)
Resective surgery with mechanical debridement
Full thickness mucoperiosteal flaps will be elevated and granulation tissue removed using surgical curettes. Hard deposits will be debrided with plastic-tipped universal curettes and sites irrigated with 20 mL sterile saline. Implant surfaces will be decontaminated by submucosal air-polishing with the Airflow Prophylaxis Master (EMS) using AIR-FLOW powder PLUS (erythritol 14 µm, amorphous silica, 0.3% chlorhexidine) at full power with irrigation. The nozzle will be changed after each implant and the handpiece moved along threads from apical to coronal positions; angulation/working distance not standardized. Surgical sites will be irrigated thoroughly with sterile saline to remove residual granulation tissue, titanium debris, or polishing particles. Flaps will then be repositioned and secured using single interrupted sutures to allow for optimal healing.
Intervention: Resective surgery with mechanical debridement (Procedure)
Outcomes
Primary Outcomes
Mean change from baseline in peri-implant probing depth (millimeters)
Time Frame: Baseline and 3 months post-surgery
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.
Secondary Outcomes
- Percentage of sites with bleeding on probing (percentage)(Baseline and 3 months post-surgery.)
- Mean modified plaque index (score)(Baseline and 3 months post-surgery)
- Mean modified gingival index (score)(Baseline and 3 months post-surgery)
- Mean implant mucosal index (score)(Baseline and 3 months post-surgery)
- Mean change from baseline in marginal bone level (millimeters)(Baseline and 3 months post-treatment)
- Mean width of keratinized mucosa(Baseline and 3 months post-surgery.)
- Elastase activity in peri-implant crevicular fluid(Baseline and 3 months post-surgery)
- Alpha-2-macroglobulin level in peri-implant crevicular fluid(Baseline and 3 months post-surgery)
- Alkaline phosphatase activity in peri-implant crevicular fluid(Baseline and 3 months post-surgery)
- Interleukin-1 beta level in peri-implant crevicular fluid(Baseline and 3 months post-surgery)
- Bray-Curtis dissimilarity of submucosal plaque microbial communities(3 months post surgery)
- Systemic immune clonal overlap frequency(Baseline and 2 weeks post-surgery.)
- Oral health-related quality of life (OHRQOL) score(Baseline and 3 months post-surgery.)
Investigators
Andrea Ravida
Assistant Professor, DDS, MS, PhD
University of Pittsburgh