Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions (Randomized Controlled Clinical Study).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Wound Closure Time
研究概览
简要总结
This clinical study aims to compare the efficacy of knotless barbed sutures versus N-butyl cyanoacrylate glue tissue adhesive for the closure of intra-oral surgical incisions, with traditional PGA vicryl sutures as a control group. The study evaluates three primary outcomes: the time required for incision closure, postoperative pain levels using the Visual Analog Scale (VAS) score, and the soft tissue healing progress using Landry's wound healing index. Secondary outcomes will include the assessment of postoperative edema and other clinical healing parameters. The goal is to determine which closure technique provides superior surgical efficiency, less patient discomfort, and better wound healing in oral and maxillofacial procedures.
详细描述
Background and Rationale:
Conventional intraoral suturing requires the placement of knots to secure the material and maintain tension. However, this presents technical challenges such as restricted access and difficulty in instrumentation. Knots are also associated with complications like food debris accumulation, microbial colonization, and tissue irritation. This study evaluates two modern alternatives-knotless barbed sutures and N-butyl cyanoacrylate glue-to overcome these limitations.
Objectives:
The primary objective is to compare the efficacy of knotless barbed sutures and N-butyl cyanoacrylate glue against traditional resorbable PGA sutures for intraoral surgical incisions. The study focuses on improving wound closure, healing, and decreasing post-operative pain and edema.
Methods:
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
- Single (Participant)
盲法说明
Participants will be blinded to the intervention groups. Due to the nature of the surgical materials, the operator cannot be blinded; however, patients will not be informed of the specific wound closure material used in their surgical site.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring Intra-oral wound closure following intra-oral incisions after surgical extraction of non-restorable teeth.
- •Good oral hygiene.
- •Highly motivated patients
- •Patients agreed to follow-up for post-operative evaluation with informed consent
- •Age between 18- 50 years old
- •Both genders: Males & Females
排除标准
- •Medically compromised patients as uncontrolled Diabetes, uncontrolled hypertension.
- •Patients on chemotherapy or radiation.
- •Patients with bad oral hygiene .
- •Uncooperative patients: mentally retarded patients.
- •Heavy smokers. ( > 1 pack/day).
结局指标
主要结局
Wound Closure Time
时间窗: Intra-operatively (at the time of surgery_
The total duration required to achieve clinical closure of the intraoral surgical incision. Measurement starts from the first needle penetration (for suture groups) or the beginning of adhesive application (for the glue group) and ends when the wound edges are fully secured.
Post-operative Pain Level
时间窗: 1st, 3rd, and 7th post-operative days.
Assessment of patient discomfort using the Visual Analogue Scale (VAS). The scale consists of a 10-cm horizontal line with "No Pain" at 0 and "Worst Imaginable Pain" at 10. Patients will mark their perceived pain level on this line.
Soft Tissue Healing
时间窗: 1st, 3rd, and 7th post-operative days.
Clinical assessment of the surgical site healing using Landry's Wound Healing Index. This index evaluates five clinical parameters: tissue color, response to palpation, presence of granulation tissue, incision margin, and presence of suppuration. Scores range from 1 (Very Poor) to 5 (Excellent).
次要结局
- Post-operative Edema(1st, 3rd, and 7th post-operative days.)
- Wound Dehiscence(1st, 3rd, and 7th post-operative days.)
研究者
Ahmed Khaled Mohamed Kenany
Master's Candidate, Department of Oral and Maxillofacial Surgery
Future University in Egypt