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

NCT06821984 | Completed

• 1 other identifier: 84 / 12.08.2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (2)

• 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.

  1 month

• Microcirculation dynamics

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

  1 week

Secondary Outcomes (2)

• Postoperative Pain Assessment Using the Visual Analog Scale (VAS)

  1 week

• Healing Assessment at Donor and Recipient Sites Using Clinical Parameters

  1 week

Study Arms (2)

cyanoacrylate (test).

EXPERIMENTAL

FGG secured using cyanoacrylate tissue adhesive without sutures.

Procedure: FGG secured using cyanoacrylate tissue adhesive without sutures.

Suture group (control)

NO INTERVENTION

GG secured with conventional sutures.

Interventions

FGG secured using cyanoacrylate tissue adhesive without sutures. PROCEDURE

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.

cyanoacrylate (test).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry Department of Periodontology

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Sutures

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Zeynep Turgut Çankaya, Ass Prof

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: his study is designed as a randomized controlled clinical trial (RCT) to evaluate the efficacy of cyanoacrylate (CA)-based adhesive in stabilizing free gingival grafts (FGG) compared to traditional sutures. The study model includes the following key components:Standardized FGG procedure performed by the same experienced periodontist. Grafts harvested from the hard palate and adapted to the recipient site. Hemostasis at the donor site managed with either traditional methods (sutures) or cyanoacrylate. Graft stabilization: Sutures (control) vs. cyanoacrylate (test).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: during the publishing
• Access Criteria: upon request with principal investigator

Locations

TU (1)