Evaluation of Cyanoacrylate as an Alternative to Sutures in Free Gingival Graft Stabilization: Effects on Graft Shrinkage, Microcirculation, and Postoperative Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Graft Shrinkage Assessed via Digital Image Analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
cyanoacrylate (test).
FGG secured using cyanoacrylate tissue adhesive without sutures.
干预措施: FGG secured using cyanoacrylate tissue adhesive without sutures. (Procedure)
Suture group (control)
GG secured with conventional sutures.
结局指标
主要结局
Graft Shrinkage Assessed via Digital Image Analysis
时间窗: 1 month
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.
Microcirculation dynamics
时间窗: 1 week
Assessed using laser Doppler flowmetry (LDF) at different time points postoperatively.
次要结局
- Postoperative Pain Assessment Using the Visual Analog Scale (VAS)(1 week)
- Healing Assessment at Donor and Recipient Sites Using Clinical Parameters(1 week)
研究者
Zeynep Turgut Çankaya
Principal Investigator
Gazi University
