Peri-implantitis
Conditions
Keywords
Peri-implantitis, Implantoplasty, Spatial transcriptomics, Salivary biomarkers
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 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
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. 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.
Interventions
PROCEDUREResective surgery with implantoplasty
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.
PROCEDUREResective surgery with mechanical debridement
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.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be enrolled, the participant must met the following inclusion criteria: 1. Aged 18 or older. 2. In good general health, classified as ASA Physical Status I or II. 3. 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
1. Patients with autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis) that could alter immune cell profiles independent of local peri-implant inflammation. 2. Chronic use of systemic corticosteroids or immunosuppressants within the past 3 months. 3. Uncontrolled diabetes (HbA1c \> 7.5%) due to its potential impact on healing and immune response. 4. Active infection or antibiotic use in the 30 days prior to baseline sampling. 5. Pregnancy or breastfeeding. 6. Inability to undergo venipuncture or tolerate soft tissue biopsy. 7. Inability to attend the 3-month follow-up visit or comply with study protocol. 8. History of malignancy requiring systemic therapy within the past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in peri-implant probing depth (millimeters) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of sites with bleeding on probing (percentage) | Baseline and 3 months post-surgery. | Bleeding on probing will be assessed at 6 sites per implant and summarized as the percentage of sites with bleeding. |
| Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome) | Baseline and 3 months post-surgery | 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. |
| Modified sulcus bleeding index (score) | Baseline and 3 months post-surgery | Peri-implant mucosal inflammation will be assessed using the modified sulcus bleeding index (mSBI) and summarized as the mean score per implant. |
| Marginal bone loss (millimeters) | Baseline and 3 months post-treatment | 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. |
| Mean Width of Keratinized Mucosa (millimeters) | Baseline and 3 months post-surgery. | 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. |
| Disease resolution (dichotomic) | 3 months, 12 months | 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. |
| Disease recurrence (dichotomic) | 2, 3, 4, and 5 years post-surgery | 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. |
| Cellular Composition of Peri-implant Tissue Assessed by Spatial Transcriptomics | Baseline and 3 months post-surgery | Peri-implant tissue samples will undergo spatial transcriptomic analysis to characterize cellular composition and compare the peri-implant tissue microenvironment between treatment groups. |
| Change in Serum Cytokine, Chemokine, and Growth Factor Levels | Baseline, 48 hours post-surgery, and 2 weeks post-surgery | 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. |
| Change in Salivary Protein Biomarker Levels | Baseline and 2 weeks post-surgery | 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. |
| Titanium Particle Density in Peri-implant Tissue (particles/mm²) | Baseline and 3 months post-surgery | 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. |
| Percentage of Peri-implant Tissue Area Occupied by Titanium Particles | Baseline and 3 months post-surgery | 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. |
Countries
United States
Contacts
CONTACTAndrea Ravida, DDS, MS, PhD
CONTACTCarla Sanchez, MS
PRINCIPAL_INVESTIGATORAndrea Ravida, DDS, MS, PhD
University of Pittsburgh, Department of Periodontics and Oral Medicine.
Outcome results
None listed