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RECRUITING
NCT07471386
NA

Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

Sponsor: Gazi University

View on ClinicalTrials.gov

Summary

This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height \< 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.

Official title: Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-01

Completion Date

2027-06-01

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

OTHER

Submucosal debridman + saline irrigation

Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness \<2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations. Participants in this group will not receive any surgical or soft tissue grafting procedures.

PROCEDURE

Free gingival graft surgery

Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness \<2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations. In this group, a free gingival graft (FGG) will be harvested from the palatal donor site under local anesthesia after completion of non-surgical therapy and resolution of acute inflammation.FGG will be stabilized using interrupted or continuous sutures. Participants will be followed for clinical and radiographic evaluations.

Locations (1)

Gazi University Faculty of Dentistry

Ankara, Turkey (Türkiye)