Peri-implantitis Management: Surgical and Maintenance Outcomes

April 27, 2026 updated by: Andrea Ravida, University of Pittsburgh

Impact of Implantoplasty on Local and Systemic Inflammation in Peri-implantitis: A Randomized Controlled 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Carla Sanchez, MS
  • Phone Number: 4126241179
  • Email: cab28@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh School of Dental Medicine
        • Contact:
          • Andrea Ravida, DDS, MS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Resective surgery with implantoplasty
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.
Active Comparator: 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.
Procedure: Resective surgery with mechanical debridement
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of sites with bleeding on probing (percentage)
Time Frame: 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.
Baseline and 3 months post-surgery.
Mean change from baseline in marginal bone level (millimeters)
Time Frame: 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; values will be averaged.
Baseline and 3 months post-treatment
Mean width of keratinized mucosa
Time Frame: 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.
Baseline and 3 months post-surgery.
Elastase activity in peri-implant crevicular fluid
Time Frame: Baseline and 3 months post-surgery
Elastase activity will be quantified in PICF using a fluorogenic substrate assay and reported per collected sample.
Baseline and 3 months post-surgery
Alpha-2-macroglobulin level in peri-implant crevicular fluid
Time Frame: Baseline and 3 months post-surgery
Alpha-2-macroglobulin will be measured in PICF by ELISA and reported per collected sample.
Baseline and 3 months post-surgery
Alkaline phosphatase activity in peri-implant crevicular fluid
Time Frame: Baseline and 3 months post-surgery
Alkaline phosphatase activity will be measured in PICF using p-nitrophenyl phosphate as substrate and reported per collected sample.
Baseline and 3 months post-surgery
Interleukin-1 beta level in peri-implant crevicular fluid
Time Frame: Baseline and 3 months post-surgery
Interleukin-1 beta will be measured in PICF using a multiplex immunoassay and reported per collected sample.
Baseline and 3 months post-surgery
Bray-Curtis dissimilarity of submucosal plaque microbial communities
Time Frame: 3 months post surgery
Microbial community differences will be summarized using Bray-Curtis dissimilarity calculated from 16S rRNA sequencing profiles.
3 months post surgery
Systemic immune clonal overlap frequency
Time Frame: Baseline and 2 weeks post-surgery.
The frequency of overlapping immune cell clones will be assessed by comparing single-cell RNA sequencing profiles from peripheral blood and gingival tissue biopsies.
Baseline and 2 weeks post-surgery.
Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome)
Time Frame: 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.
Baseline and 3 months post-surgery
Modified gingival index (score)
Time Frame: Baseline and 3 months post-surgery
Peri-implant mucosal inflammation will be assessed using the modified gingival index (mGI) and summarized as the mean score per implant.
Baseline and 3 months post-surgery
Implant mucosal index (IMI) (score on a scale, 0-4; higher score = worse outcome)
Time Frame: Baseline and 3 months post-surgery
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.
Baseline and 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Andrea Ravida, DDS, MS, PhD, University of Pittsburgh, Department of Periodontics and Oral Medicine.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY25070066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research study data will be stored separately from medical records. Consent forms and copies of letters/correspondence will be stored separately from the research data. Data will be coded with a participant code number which will be assigned consecutively as subjects are enrolled. There will be an excel spreadsheet containing the linkage code to the identifiable patient name or Axium number. This spreadsheet will be password protected and only accessible to the research team and will be saved in a separate location then the medical records (such as OneDrive).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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