Clinical trial NCT06821984: Evaluation of Cyanoacrylate as an Alternative to Sutures in Free Gingival Graft Stabilization
Official title: Evaluation of Cyanoacrylate as an Alternative to Sutures in Free Gingival Graft Stabilization: Effects on Graft Shrinkage, Microcirculation, and Postoperative Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Graft Shrinkage Assessed via Digital Image Analysis
timeFrame: 1 month
measure: Microcirculation dynamics
timeFrame: 1 week
Secondary outcomes:
measure: Postoperative Pain Assessment Using the Visual Analog Scale (VAS)
timeFrame: 1 week
measure: Healing Assessment at Donor and Recipient Sites Using Clinical Parameters
timeFrame: 1 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry Department of Periodontology
state: Çankaya
Study officials:
affiliation: Gazi University
name: Zeynep Turgut Çankaya, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: