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 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.

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Conditions

Peri-implantitis

Study ID

NCT07550127

Start date

Feb 16, 2026

Status verified date

Sep, 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. The implant surface will be cleaned using mechanical debridement with titanium curettes and ultrasonic instruments. In the test group, implantoplasty will be performed using rotary instruments to smooth and reduce implant surface roughness. All implant surfaces will be irrigated with sterile saline before suturing. Flaps will then be repositioned and secured using single interrupted sutures.

active comparator: Resective surgery with mechanical debridement

Full-thickness mucoperiosteal flaps will be elevated, and granulation tissue will be removed using surgical curettes. The implant surface will be cleaned using mechanical debridement with titanium curettes and ultrasonic instruments. In the control group, air polishing will be performed using the Airflow Prophylaxis Master with AIR-FLOW powder PLUS containing erythritol (14 µm), amorphous silica, and 0.3% chlorhexidine. All implant surfaces will be irrigated with sterile saline before suturing. Flaps will then be repositioned and secured using single interrupted sutures.

Interventions

Resective 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.

Resective 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.

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

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Peri-implantitis
  • Implantoplasty
  • Spatial transcriptomics
  • Salivary biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.