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NCT Number: NCT07550127

Peri-implantitis Management: Surgical and Maintenance Outcomes

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Andrea Ravida, DDS, MS, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resective surgery with implantoplasty

Procedure

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.

Resective surgery with mechanical debridement

Procedure

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Ravida, DDS, MS, PhD

CONTACT

[email protected]

7347309678

Carla Sanchez, MS

CONTACT

[email protected]

4126241179

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 24, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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