Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

Sponsor
Gazi University
Study ID
NCT07471386
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Submucosal debridman + saline irrigation — OTHER
    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.
  • Free gingival graft surgery — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Apr 1, 2027
Completion
Jun 1, 2027

Study Design

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

Arms

  • Active Comparator: Control group
    Non-surgical treatment of peri-implantitis alone
  • Active Comparator: Test Group
    Non-surgical treatment of perı-implantitis + Free gingival graft procedure

Primary Outcome Measure

Change in PPD [ Time Frame: Following at 12. months post-treatment ]

Central Contacts

Related Studies