Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 13, 2026
January 1, 2026
1.1 years
March 10, 2026
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in PPD
Following at 12. months post-treatment
Secondary Outcomes (4)
Bleeding on Probing
Following at 12. months post-treatment
Plaque index
Following at 12. months post-treatment
Keratinized mucosa width
Following at 12. months post-treatment
Keratinized mucosa thickness
Following at 12. months post-treatment
Study Arms (2)
Control group
ACTIVE COMPARATORNon-surgical treatment of peri-implantitis alone
Test Group
ACTIVE COMPARATORNon-surgical treatment of perı-implantitis + Free gingival graft procedure
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Non-smoker
- Systemically healthy
- Keratinized mucosa witdh \< 2 mm
You may not qualify if:
- İntake of medications that impede periodontal tissue health and healing
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi University Faculty of Dentistry
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sila Cagri Isler, Prof Dr
Gazi University Faculty of Dentistry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Dr
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 13, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share