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Gingival RecessionNCT06821984

Evaluation of Cyanoacrylate as an Alternative to Sutures in Free Gingival Graft Stabilization

A study testing FGG secured using cyanoacrylate tissue adhesive without sutures. in people with Gingival Recession, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Free gingival graft (FGG) is a widely used periodontal plastic surgery technique for treating gingival recession, increasing keratinized gingiva width, and enhancing peri-implant soft tissues. Despite its predictable outcomes, donor site morbidity, postoperative pain, and graft contraction remain challenges. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
FGG secured using cyanoacrylate tissue adhesive without sutures.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2019to 1 Sep 2020
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

  • Presence of at least one site with <2 mm of keratinized tissue, diagnosed using the functional test (borderline between movable and immovable tissue) [36].
  • Limited to the lower central and lateral incisors, canines, and first and second premolars in each patient.

Who cannot join

  • Gingival thickness ≥1 mm. Absence of a pulling frenum in the keratinized tissue. No parafunctional habits. No history of mucogingival or periodontal surgery. No restorations or crown prostheses.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Faculty of Dentistry Department of Periodontology

    Ankara, Çankaya, 06510

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Cyanoacrylate as an Alternative to Sutures in Free Gingival Graft Stabilization: Effects on Graft Shrinkage, Microcirculation, and Postoperative Healing

Free gingival graft (FGG) is a widely used periodontal plastic surgery technique for treating gingival recession, increasing keratinized gingiva width, and enhancing peri-implant soft tissues. Despite its predictable outcomes, donor site morbidity, postoperative pain, and graft contraction remain challenges.

This study evaluates the efficacy of cyanoacrylate for securing FGGs without sutures at the recipient site and accelerating donor site healing. Laser Doppler flowmetry (LDF) and digital measurement techniques were used to objectively assess microcirculation and graft shrinkage.

Read more

Although previous research has investigated dimensional changes and vascular dynamics in FGG healing, no study has assessed absolute area changes in cyanoacrylate-fixed grafts or its impact on microcirculation at both the donor and recipient sites.

This randomized controlled clinical trial compares cyanoacrylate and suture fixation in early healing, focusing on graft shrinkage, microcirculation, and postoperative pain. By analyzing the effects of cyanoacrylate on wound healing and blood flow, this study aims to optimize surgical outcomes and improve patient recovery.

Read the detailed description

Free gingival graft (FGG) is a widely used periodontal plastic surgery technique for treating gingival recession, increasing keratinized gingiva width, and enhancing peri-implant soft tissues. This procedure helps improve oral hygiene by creating a keratinized tissue barrier that resists frictional forces. While FGG is considered the gold standard due to its predictable success, donor site healing remains a challenge, often associated with postoperative pain, bleeding, and discomfort.

FGG involves two wound sites: the recipient and the donor site. The donor site, typically the hard palate, heals by secondary intention. Research has focused on minimizing donor site morbidity by exploring various biomaterials, growth factors, and wound healing strategies, such as platelet-rich fibrin (PRF), laser therapy, and chemotherapeutic agents. Covering the donor site aims to reduce bacterial contamination, accelerate healing, and decrease pain. Recent advancements in biomaterials and tissue adhesives have been explored to optimize this process.

At the recipient site, graft adaptation and long-term stability are crucial for success. Proper vascularization, integration, and esthetic outcomes depend on biological responses and surgical techniques. Traditional suturing methods, while effective, contribute to graft contraction due to tissue trauma and increased hematoma formation. Alternative stabilization methods, such as fibrin glue, staples, adhesive tapes, and cyanoacrylate-based adhesives, have been explored to minimize these effects.

Cyanoacrylate (CA)-based adhesives are promising biomaterials for tissue fixation due to their high adhesion strength, rapid polymerization, and stability in moist environments. First introduced for FGG stabilization by Hoexter in 1978, CA adhesives have demonstrated bacteriostatic properties, slow biodegradability, and reduced postoperative pain compared to sutures. Butyl cyanoacrylate (BCA) adhesives, in particular, provide hemostatic effects and facilitate rapid wound closure, potentially reducing complications such as graft shrinkage and donor site bleeding.

Previous studies on FGG contraction assumed uniform linear shrinkage, which may not accurately reflect the actual healing process. Digital measurement techniques provide more precise assessments by accounting for the irregular surface morphology of healing grafts. Additionally, microcirculatory changes play a critical role in graft survival, with vascular connections forming by the third day and sinusoidal vascular loops developing by day five (Nobuto et al., 1988). Laser Doppler flowmetry (LDF) is a non-invasive tool used to evaluate blood flow dynamics in gingival wound healing, providing objective and repeatable microcirculatory data.

Despite existing research on FGG healing and donor site dynamics, no study has comprehensively assessed the absolute area changes of cyanoacrylate-secured grafts or its impact on microcirculation at both the donor and recipient sites. This randomized controlled clinical trial aims to compare suture fixation and cyanoacrylate tissue adhesives during early healing. Key parameters include graft shrinkage, microcirculation, and postoperative pain.

By integrating LDF and digital measurement techniques, this study seeks to provide objective data on the effects of cyanoacrylate on blood flow and tissue healing. The findings may contribute to optimizing surgical outcomes, improving patient comfort, and reducing complications associated with FGG procedures.

Being tested
FGG secured using cyanoacrylate tissue adhesive without sutures.
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FGG secured using cyanoacrylate tissue adhesive without sutures.Procedure or surgery

    The intervention involved securing the free gingival graft (FGG) using cyanoacrylate adhesive instead of conventional sutures. After harvesting the graft from the hard palate, hemostasis at the donor site was achieved with gauze compression. The recipient site was prepared with a partial-thickness dissection to ensure a stable graft bed. In the intervention group, cyanoacrylate adhesive was applied along the margins of the graft and underlying periosteal bed, ensuring complete coverage without the use of sutures. The adhesive polymerized within seconds, creating an immediate bond between the graft and recipient site, minimizing micro-movements and reducing the need for additional fixation.

Study groups in NCT06821984
Study groupRoleWhat they receive
cyanoacrylate (test).ExperimentalFGG secured using cyanoacrylate tissue adhesive without sutures.
Receives: Procedure: FGG secured using cyanoacrylate tissue adhesive without sutures.
Suture group (control)No interventionGG secured with conventional sutures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Graft Shrinkage Assessed via Digital Image Analysis

    Graft shrinkage is measured digitally using image analysis software to assess dimensional stability over time. Standardized clinical photographs are taken at predefined time points, and changes in graft dimensions are quantified using calibrated digital measurement tools. Measurements include changes in graft surface area and linear contraction over the follow-up period.

    Measured: 1 month

  2. Microcirculation dynamics

    Assessed using laser Doppler flowmetry (LDF) at different time points postoperatively.

    Measured: 1 week

Secondary outcomes (2)
  1. Postoperative Pain Assessment Using the Visual Analog Scale (VAS)

    Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10 cm linear scale ranging from 0 to 10. The minimum value (0) represents 'no pain,' while the maximum value (10) indicates 'worst imaginable pain.' Higher scores correspond to greater pain intensity, indicating a worse outcome.

    Measured: 1 week

  2. Healing Assessment at Donor and Recipient Sites Using Clinical Parameters

    Healing at donor and recipient sites will be evaluated using clinical parameters, including epithelialization, wound closure, and presence of inflammation. Healing will be assessed at predefined time points through standardized clinical examination by a calibrated periodontist. Each parameter will be graded using Gingival Indices (0-3), where 0 indicates no healing/inflammation and 3 represents complete healing/no inflammation. Higher scores indicate better healing outcomes

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Sep 2020

Resources

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
Parallel-group randomized controlled trial Two intervention groups: Suture group (control): FGG secured with conventional sutures. Cyanoacrylate group (test): FGG secured using cyanoacrylate tissue adhesive without sutures.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06821984
Sponsor's protocol ID
84 / 12.08.2018
Status last verified
Feb 2025
First submitted
5 Feb 2025
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon Request

Questions about this trial

What is this clinical trial studying?

A study testing FGG secured using cyanoacrylate tissue adhesive without sutures. in people with Gingival Recession, run by Gazi 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 2 inclusion and 1 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 12 Feb 2025. 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?

Graft Shrinkage Assessed via Digital Image Analysis (time frame: 1 month). The study lists 2 primary outcomes in all. 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 12 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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