Peri-implantitis Management: Surgical and Maintenance Outcomes

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07550127
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Resective surgery with implantoplasty — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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

Key Dates

First listed
Apr 24, 2026
Start date
Feb 16, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh School of Dental MedicinePittsburghPennsylvania15213
Andrea Ravida, DDS, MS, PhD

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University of Pittsburgh School of Dental Medicine· Pittsburgh, PA

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