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Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

NCT07471386 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Peri-implantitis
  • Soft Tissue Augmentation at Dental Implants

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Sila Cagri Isler, Prof Dr · Gazi University Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-04-01
Completion
2027-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471386 on ClinicalTrials.gov