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临床试验/CTRI/2024/09/074009
CTRI/2024/09/074009尚未招募4 期

Comparative evaluation of rate of extraction space closure between early and delayed therapeutic 1st premolar extraction in bimaxillary protrusion patients using mini implants. A Randomized Controlled Trial

Dr Mohamed Shamsudeen A I1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Rate of extraction space closure in early and delayed extraction of 1st premolars

研究概览

简要总结

This study is a randomized, parallel group trial investigating in Bimaxillary protrusion patients the effect of early versus delayed extraction (premolar) on the speed of tooth movement in orthodontic treatment by using mini implants. The primary outcome of the study is to compare and evaluate the rate of extraction space closure in early and delayed extraction of 1st premolars for the period of 20 months. The secondary outcomes is to assess root resorption of maxillary anterior teeth pre-treatment and post-retraction and also to assess Tooth angulation of maxillary incisor teeth pre-treatment and post-retraction for the period of 20 months. Total sample size was calculated to be 30 including expected dropout rate of 20 %.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Class 1 bi-maxillary protrusion without any impacted teeth in maxillary and mandibular anterior region.
  • 2.Cases requiring extraction of both maxillary and mandibular first premolar 3.Little’s index for crowding: 1- 3 mm (minimal crowding) 4.Adult patients 18-35 years of age, both male and female.
  • 5.Patients with periodontally sound dentition.
  • 6.Patients with good general health.

排除标准

  • 1.Skeletal/Dental class II malocclusion 2.Skeletal/Dental class III malocclusion 3.Poor oral hygiene 4.Smoking.

结局指标

主要结局

Rate of extraction space closure in early and delayed extraction of 1st premolars

时间窗: 20 months

次要结局

  • To assess Root resorption of maxillary anterior teeth pre-treatment and post-retraction(20 months)
  • To assess Tooth angulation of maxillary incisor teeth pre-treatment and post-retraction(20 months)

研究者

发起方
Dr Mohamed Shamsudeen A I
申办方类型
Other [(self funding)]
责任方
Principal Investigator
主要研究者

Dr Mohamed Shamsudeen

Government Dental College and Hospital, Cuddalore

研究点 (1)

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