Recruiting

Resective Surgery & Implantoplasty

Sponsor:

University of Pittsburgh

Code:

NCT07550127

Conditions

Peri-implantitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Resective surgery with implantoplasty

Resective surgery with mechanical debridement

Study Details

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.

Conditions

Peri-implantitis

Study ID

NCT07550127

Start date

Feb 16, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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

Primary outcome measure

  • Mean change from baseline in peri-implant probing depth (millimeters) [ Time Frame: Baseline and 3 months post-surgery ]

Central Contacts and Locations

Central contacts

Andrea Ravida, DDS, MS, PhD

7347309678andrearavida@pitt.edu

Carla Sanchez, MS

4126241179cab28@pitt.edu

Locations

University of Pittsburgh School of Dental Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

University of Pittsburgh

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Peri-implantitis
  • Implantoplasty
  • Single-cell RNA sequencing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-01.