Comparative analysis of clinical outcomes using polydioxanone, polyglecaprone 25 AND polyglactin 910 sutures in impacted third molar surgeries - Randomised control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Infection Rates – Assessing the incidence of post-operative infections in each group.
研究概览
简要总结
This study aims to assess and compare the clinical outcomes of knotless barbed sutures, monofilament resorbable sutures, and resorbable multifilament sutures in impacted mandibular third molar surgeries, with focus on wound healing, infection rates, post-operative complications, and patient comfort. Through a randomized controlled trial, patients will be assigned to one of the three suture groups: knotless barbed sutures (Polydioxanone), monofilament resorbable sutures (Monocryl), or multifilament sutures (Vicryl). The primary outcomes include healing time, infection rates, incidence of post-operative pain, swelling, and overall patient comfort. Traditional sutures, such as Vicryl, are associated with higher infection risks due to their multifilament structure, which can harbor bacteria, and complications such as knot slippage, inadequate tension, or irritation. Monofilament sutures, while better at reducing bacterial colonization, still rely on knots, which can lead to tissue irritation and delayed healing. In contrast, knotless barbed sutures (Polydioxanone) offer a game-changing advancement by eliminating the need for knots, reducing surgical time, minimizing tissue irritation, and preventing complications like knot-related slippage or ischemia.. This study seeks to provide insights into the most effective suture materials, ultimately optimizing surgical outcomes, reducing complications, and enhancing patient satisfaction and comfort in third molar extractions. By addressing these critical issues, this research promises to improve clinical practices, reduce recovery time, and transform the patient experience .
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with at least one impacted mandibular third molar requiring surgical removal.
- •ASA Grade I and II Willingness to abide and comply with the protocol requirement and visits for follow-up.
排除标准
- •Medically compromised patients Active pus discharge, infection at the operative site Tobacco users Pregnant women.
结局指标
主要结局
Infection Rates – Assessing the incidence of post-operative infections in each group.
时间窗: at 3 days , one week , 10 days and 15 days
Post-Operative Pain – Measuring pain levels using a standardized pain scale over a set period.
时间窗: at 3 days , one week , 10 days and 15 days
The primary outcomes of the study will be:
时间窗: at 3 days , one week , 10 days and 15 days
Healing Time – Evaluating how quickly the surgical site heals with each suture type.
时间窗: at 3 days , one week , 10 days and 15 days
Swelling – Comparing post-operative edema across the three suture groups.
时间窗: at 3 days , one week , 10 days and 15 days
Patient Comfort – Assessing factors like irritation, tightness, or discomfort related to the suture material.
时间窗: at 3 days , one week , 10 days and 15 days
次要结局
- Patient Comfort – Assessing factors like irritation, tightness, or discomfort related to the suture material.(at one week , & fifteen days)