跳至主要内容
临床试验/NCT05679973
NCT05679973已完成不适用

Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery

Yuzuncu Yil University2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Trismus evaluation

研究概览

简要总结

This study aimed to evaluate the efficacy of polybutester sutures on postoperative complications in lower impacted third molar surgery.

详细描述

After extraction of the bilateral lower third molars (35 patients), two different types of sutures were used on each side. Group 1( Polybutester suture) , group 2 (Polypropylene suture). Measurements to evaluate edema, trismus, and pain (using the VAS scale) had been taken pre-procedure and post-procedure( 2nd and 7th day )

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Any medication until 2 weeks before the operations,
  • Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell & Gregory classification,
  • Asymptomatic impacted teeth.
  • Coming to control and fill in the given and requested forms,
  • Regularly use the given drugs

排除标准

  • Systemic disease,
  • Pregnancy or breastfeeding,
  • Allergy to the drugs to be used in the study,
  • Using any additional medication that may affect the outcome of the study,
  • Post-operative alveolitis.

结局指标

主要结局

Trismus evaluation

时间窗: Postoperative 7th day

Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.

Edema evaluation

时间窗: Postoperative 7th day

Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.

Trismus Evaluation

时间窗: Preoperative

Preoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which were measured with a caliper.

Pain Evaluation

时间窗: Postoperative 7th day

Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).

Edema evaluation using Facial measurement

时间窗: Postoperative 2nd day

Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

levent Cigerim

Head of Oral and Maxillofacial Surgery Department

Yuzuncu Yil University

研究点 (2)

Loading locations...

相似试验