Insufficient Keratinized TissueNCT07359300
Cyanoacrylate Versus Sutures for Free Gingival Graft Stabilization
A study testing Free Gingival Graft Stabilization With Butyl-Cyanoacrylate and Free Gingival Graft Stabilization With Sutures in people with Insufficient Keratinized Tissue and Gingival Recession, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial evaluated the effectiveness of butyl-cyanoacrylate tissue adhesive compared with conventional sutures for stabilization of free gingival grafts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insufficient Keratinized Tissue, Gingival Recession, Mucogingival Defects
- What is being tested?
- Free Gingival Graft Stabilization With Butyl-Cyanoacrylate and Free Gingival Graft Stabilization With Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Free Gingival Graft Stabilization With Butyl-Cyanoacrylate, Free Gingival Graft Stabilization With Sutures
- Keywords
- Free gingival graft, Cyanoacrylate, Sutures, Keratinized tissue, Randomized clinical trial
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival Graft Stabilization With Butyl-CyanoacrylateProcedure or surgery
Stabilization of free gingival grafts using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery.
Free Gingival Graft Stabilization With SuturesProcedure or surgery
Stabilization of free gingival grafts using non-resorbable polypropylene sutures following standard free gingival graft surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate Stabilization Group | Experimental | Free gingival grafts were stabilized using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery. Receives: Procedure: Free Gingival Graft Stabilization With Butyl-Cyanoacrylate |
| Suture Stabilization Group | Active comparator | Free gingival grafts were stabilized using non-resorbable polypropylene sutures following standard free gingival graft surgery. Receives: Procedure: Free Gingival Graft Stabilization With Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Keratinized Tissue Width
Change in keratinized tissue width measured at the surgical sites using a periodontal probe.
Measured: Baseline and 6 months postoperatively
Secondary outcomes (8)
Total Graft Surface Area (TGSA)
Changes in total graft surface area assessed using standardized clinical photographs and digital measurements.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Vertical Graft Height (VGH)
Changes in vertical graft height assessed using standardized clinical photographs and digital measurements.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Probing Depth (PD)
Changes in probing depth measured at the surgical sites using a periodontal probe.
Measured: Baseline and 6 months postoperatively
Vertical Recession (VR)
Changes in vertical gingival recession measured at the surgical sites using a periodontal probe.
Measured: Baseline and 6 months postoperatively
Full-Mouth Plaque Score (FMPS)
Changes in full-mouth plaque score assessed to evaluate oral hygiene status.
Measured: Baseline and 6 months postoperatively
Full-Mouth Bleeding Score (FMBS)
Changes in full-mouth bleeding score assessed to evaluate periodontal inflammation.
Measured: Baseline and 6 months postoperatively
Postoperative Pain and Discomfort
Patient-reported postoperative pain and discomfort assessed using a visual analogue scale (VAS).
Measured: Day 0 to Day 6 postoperatively
Operative Time
Duration of the surgical procedure measured from the initial incision to completion of graft stabilization.
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Keratinized TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups to receive free gingival graft stabilization using either butyl-cyanoacrylate tissue adhesive or conventional sutures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Burcu Yıldırım, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359300
- Sponsor's protocol ID
- YEDITEPE-FGG-2019-01
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Cyanoacrylate and Sutures for Free Gingival Graft Stabilization
- ClinicalTrials.gov ID
- NCT07359300
- Acronym / sponsor ID
- YEDITEPE-FGG-2019-01
- Keywords
- Free gingival graft, Cyanoacrylate, Sutures, Keratinized tissue, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups to receive free gingival graft stabilization using either butyl-cyanoacrylate tissue adhesive or conventional sutures.
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate Stabilization Group | Experimental | Procedure: Free Gingival Graft Stabilization With Butyl-CyanoacrylateFree gingival grafts were stabilized using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery. |
| Suture Stabilization Group | Active comparator | Procedure: Free Gingival Graft Stabilization With SuturesFree gingival grafts were stabilized using non-resorbable polypropylene sutures following standard free gingival graft surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Gingival Graft Stabilization With Butyl-CyanoacrylateStabilization of free gingival grafts using butyl-cyanoacrylate tissue adhesive following standard free gingival graft surgery. | Procedure or surgery | Cyanoacrylate Stabilization Group |
| Free Gingival Graft Stabilization With SuturesStabilization of free gingival grafts using non-resorbable polypropylene sutures following standard free gingival graft surgery. | Procedure or surgery | Suture Stabilization Group |
Primary outcome
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.
8 secondary outcomes
Total Graft Surface Area (TGSA)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Vertical Graft Height (VGH)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Probing Depth (PD)
Time frame: Baseline and 6 months postoperatively
Vertical Recession (VR)
Time frame: Baseline and 6 months postoperatively
Full-Mouth Plaque Score (FMPS)
Time frame: Baseline and 6 months postoperatively
Full-Mouth Bleeding Score (FMBS)
Time frame: Baseline and 6 months postoperatively
Postoperative Pain and Discomfort
Time frame: Day 0 to Day 6 postoperatively
Operative Time
Time frame: During the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Insufficient Keratinized Tissue
Recruiting
Fixation of Free Gingival Graft Using Tissue Tacks vs Criss-cross Sutures
Lack of Keratinized Tissue
Recruiting
CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
Enrolling by invitation
Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage
Gingival Recession, Mucogingival Deformity - Insufficient Keratinized Tissue
Recruiting
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Lack of Keratinized Gingiva, Mucogingival Deformity - Insufficient Keratinized Tissue
Recruiting
Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique
Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft Stabilization With Butyl-Cyanoacrylate and Free Gingival Graft Stabilization With Sutures in people with Insufficient Keratinized Tissue and Gingival Recession, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Keratinized Tissue Width (time frame: Baseline and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.