Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

ConditionsPeri-implantitis Soft Tissue Augmentation at Dental Implants

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorGazi University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Non-smoker

Systemically healthy

Keratinized mucosa witdh < 2 mm

Disqualifiers

İntake of medications that impede periodontal tissue health and healing

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

Submucosal debridman + saline irrigation
Other intervention
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/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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Test GroupActive comparator 1 intervention