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临床试验/CTRI/2024/04/065383
CTRI/2024/04/065383招募中4 期

Evaluation of efficacy of v-loc knotless wound closure system vs silk suture in impacted third molar surgery -a split mouth randomised controlled clinical trial.

Dr Geetha sridaran1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
34
试验地点
1
主要终点
This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive.

研究概览

简要总结

OBJECTIVES:

  1. To check the efficacy and feasibility of V-Loc knotless wound closure systemin the field of maxillofacial surgery.

To compare the potential difference between V-Loc knotless wound closure system with silk sutures. 3. To compare the wound healing and infection rate between both the groups.

METHEDOLOGY: This is a split mouth randomised controlled clinical trial to compare the efficacy of V-Loc knotless wound closure system and silk sutures.Based on the inclusion criteria patients will be taken into the study. An approximate of 20 patients will be subjected to the study with orthopantomogram to confirm and identify bilateral symmetrically impacted third molar teeth, patients will be divided and allocated to the study and control group randomly. All the patients will be operated by single surgeon. Patients will be operated on both sides on the same day under local anaesthesia by following standard surgical protocol. Wound closure will be done by V-Loc knotless wound closure system on one side and 3-0 silk sutures on the other side.Following the procedure patients will be assessed based on these post operative findings like pain (VAS), swelling (3point value), wound healing (Laundry’s scale), Maximum inter incisal opening (mouth opening), time taken to achieve wound closure and haemostasis and rate of infection. Patients will be reviewed on post operative day 3, 5,7 and 14, values will be recorded and will be analysed statistically accordingly.

INCLUSION CRITERIA: 1. 2. Subjects between the age group of 18-40 years. Subjects with nil oral habits (Example: Smoking, Pan chewing) 3. Subjects with no co-morbid conditions (Example: Diabetes, Hypertension and bleeding disorders etc.) 4. Subjects who require therapeutic removal of 3" molars.

EXCLUSION CRITERIA: 1. Subjects who are pregnant and lactating.2. Subjects with prosthetic valves and stents. 3. Subjects on anti-platelet and anti-coagulants. 4. Subjects with any cysts, abscess, and or developmental disorders.

IMPLICATIONS: This study is expected to have an impact on the field of maxillofacial surgery when new V-Loc knotless wound closure system is proved to be efficient in controlling haemorrhage, infection, enhance wound healing, wound closure time is reduced and less technique sensitive. To prove the efficiency of V-Loc knotless wound closure system over silk sutures.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • patient with nil oral habits, examples: smoking, pan chewing.
  • patient with co-morbid conditions, example: diabetes, hypertension, bleeding disorders.
  • patient who require therapeutic removal of third molar.

排除标准

  • patients with prosthetic valves and stents.
  • patients with any cysts ,abscess and developmental disorders.
  • patients on anti-platelet and anti- coagulants.
  • patients who are pregnant and lactating.

结局指标

主要结局

This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive.

时间窗: This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive. | to analyze patient comfort and interpret the results and incoporate them in our daily dental practice. With a follow up of baseline ,3 day ,5 day, one week and second week.

to analyze patient comfort and interpret the results and incorporate them in our daily dental practice.

时间窗: This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive. | to analyze patient comfort and interpret the results and incoporate them in our daily dental practice. With a follow up of baseline ,3 day ,5 day, one week and second week.

次要结局

未报告次要终点

研究者

发起方
Dr Geetha sridaran
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

krithic chitra banu

Meenakshi ammal dental college

研究点 (1)

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