Surgical Treatments for Peri-Implantitis
What You Need to Know Before You Apply
What is the purpose of this 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.
Who Is on the Research Team?
Andrea Ravida, DDS, MS, PhD
Principal Investigator
University of Pittsburgh, Department of Periodontics and Oral Medicine.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo resective surgery with either implantoplasty or mechanical debridement
Treatment
Participants undergo resective surgery with either implantoplasty or mechanical debridement
Follow-up
Participants are monitored for safety and effectiveness after treatment, with gingival tissue biopsy and peri-implant crevicular fluid collection
Post-surgery Monitoring
Blood samples collected at 48 hours and 2 weeks post-surgery; gingival tissue and PICF collected at baseline and 3 months post-surgery
Maintenance
Participants are followed in a structured supportive care program with regular visits
Follow-up
Participants are monitored in a structured supportive care program with visits every 3 months
What Are the Treatments Tested in This Trial?
Interventions
- Resective surgery with implantoplasty
- Resective surgery with mechanical debridement
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
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