NCT07204717

Brief Summary

Objective Peri-implant keratinized mucosa deficiency is a significant factor affecting implant success. Therefore, it is crucial to choose a suitable technique for increasing the width of the keratinized mucosa. This study aims to compare two different approaches of free gingival graft (FGG) application in the treatment of insufficient peri-implant keratinized mucosa and to determine the most effective and predictable technique. Materials and Methods A total of 38 systemically healthy patients with ≤2 mm of keratinized mucosa in the mandibular anterior region (teeth 33-43) and 38 dental implants were included. Patients were randomly assigned to two groups: Test ( Ring FGG) and Control (Conventional FGG). Clinical parameters including Bleeding on Probing (BOP), Gingival Index (GI), Plaque Index (PI), Probing Depth (PD), Width of Keratinized Mucosa (KMW), Peri-implant Mucosal Thickness (PMT), and Graft Surface Area (GSA) were recorded at baseline, and at 1, 3, and 12 months postoperatively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

September 19, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

Dental ImplantKeratinized Mucosa.Rıng free gingival graftFree gingival graft

Outcome Measures

Primary Outcomes (1)

  • keratinize gingiva

    increasing the amount of keratinized gingiva

    2 week

Study Arms (2)

ring free gingival graft

EXPERIMENTAL

ring free gingival graft

Procedure: ring free gingival greft

standard free gingival technique

ACTIVE COMPARATOR

standard techinique

Procedure: free gingival graft

Interventions

standard free gingival technique

standard free gingival technique

ring free gingival greft technique

Also known as: ring free gingival
ring free gingival graft

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale and female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Systemically healthy individuals 2. Age over 18 years 3. Non-smokers 4. No antibiotic therapy for any reason in the past 6 months 5. No previous soft tissue surgery performed in the region of interest 6. KMW≤ 2 mm 7. Presence of inadequate keratinized tissue in the vestibular and/or lingual area of the anterior mandibular implant region 8. Mentally competent to understand the study purpose and procedures explained both verbally and in writing

You may not qualify if:

  • \- 1. Presence of peri-implantitis in the implant(s) planned for FGG application (defined as probing depth ≥ 5 mm, pus discharge, mobility, or severe bone loss) 2. Inability to maintain oral hygiene or presence of implant body and/or abutment fractures in the related region 3. Presence of pathological conditions in the palate that prevent harvesting of a free gingival graft 4. History of systemic diseases such as Diabetes Mellitus, Chronic Renal Failure, Cancer, Bleeding Disorders, Connective Tissue Diseases, etc.
  • \. Use of anticoagulant and/or antiplatelet medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Bolu Abant İzzet Baysal University,

Bolu, Bolu, 14100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 19, 2025

First Posted

October 2, 2025

Study Start

October 21, 2018

Primary Completion

July 15, 2020

Study Completion

August 20, 2020

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations