- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359300
Cyanoacrylate Versus Sutures for Free Gingival Graft Stabilization
January 14, 2026 updated by: Kübra Burcu Yıldırım, Yeditepe University
A Randomized Controlled Clinical Trial Comparing Cyanoacrylate and Sutures for Free Gingival Graft Stabilization
This randomized controlled clinical trial evaluated the effectiveness of butyl-cyanoacrylate tissue adhesive compared with conventional sutures for stabilization of free gingival grafts.
Twenty-four patients with insufficient keratinized tissue were randomly assigned to either cyanoacrylate or suture stabilization following free gingival graft surgery.
Clinical parameters, graft dimensional changes, patient-reported postoperative discomfort, and operative time were assessed over a 6-month follow-up period.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Yeditepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Presence of ≤1 mm of keratinized tissue and/or Miller Class I gingival recession ≤2 mm affecting one to four mandibular anterior teeth
- Vital teeth in the surgical area
- Good oral hygiene following initial periodontal therapy (full-mouth plaque score and full-mouth bleeding score ≤20%)
- Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Current smokers
- Pregnancy or lactation
- Use of systemic antibiotics within the previous 6 months
- History of periodontal surgery in the study area
- Ongoing orthodontic treatment
- Systemic conditions that could affect periodontal healing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cyanoacrylate Stabilization Group
Free gingival grafts were stabilized using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery.
|
Stabilization of free gingival grafts using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery.
|
|
Active Comparator: Suture Stabilization Group
Free gingival grafts were stabilized using non-resorbable polypropylene sutures following standard free gingival graft surgery.
|
Stabilization of free gingival grafts using non-resorbable polypropylene sutures following standard free gingival graft surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Keratinized Tissue Width
Time Frame: Baseline and 6 months postoperatively
|
Change in keratinized tissue width measured at the surgical sites using a periodontal probe.
|
Baseline and 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Graft Surface Area (TGSA)
Time Frame: Baseline, 1 month, 3 months, and 6 months postoperatively
|
Changes in total graft surface area assessed using standardized clinical photographs and digital measurements.
|
Baseline, 1 month, 3 months, and 6 months postoperatively
|
|
Vertical Graft Height (VGH)
Time Frame: Baseline, 1 month, 3 months, and 6 months postoperatively
|
Changes in vertical graft height assessed using standardized clinical photographs and digital measurements.
|
Baseline, 1 month, 3 months, and 6 months postoperatively
|
|
Probing Depth (PD)
Time Frame: Baseline and 6 months postoperatively
|
Changes in probing depth measured at the surgical sites using a periodontal probe.
|
Baseline and 6 months postoperatively
|
|
Vertical Recession (VR)
Time Frame: Baseline and 6 months postoperatively
|
Changes in vertical gingival recession measured at the surgical sites using a periodontal probe.
|
Baseline and 6 months postoperatively
|
|
Full-Mouth Plaque Score (FMPS)
Time Frame: Baseline and 6 months postoperatively
|
Changes in full-mouth plaque score assessed to evaluate oral hygiene status.
|
Baseline and 6 months postoperatively
|
|
Full-Mouth Bleeding Score (FMBS)
Time Frame: Baseline and 6 months postoperatively
|
Changes in full-mouth bleeding score assessed to evaluate periodontal inflammation.
|
Baseline and 6 months postoperatively
|
|
Postoperative Pain and Discomfort
Time Frame: Day 0 to Day 6 postoperatively
|
Patient-reported postoperative pain and discomfort assessed using a visual analogue scale (VAS).
|
Day 0 to Day 6 postoperatively
|
|
Operative Time
Time Frame: During the surgical procedure
|
Duration of the surgical procedure measured from the initial incision to completion of graft stabilization.
|
During the surgical procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
August 1, 2021
Study Registration Dates
First Submitted
January 14, 2026
First Submitted That Met QC Criteria
January 14, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YEDITEPE-FGG-2019-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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