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临床试验/CTRI/2024/03/064374
CTRI/2024/03/064374已完成4 期

Comparative evaluation of moisture insensitive and conventional based orthodontic adhesive systems: A Randomised Control trial.

Radheya Agrawal1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
616
试验地点
1
主要终点
BOND FAILURE RATE

研究概览

简要总结

**Orthodontic treatment with brackets generall****y takes 1-2 years of time.**Most of the current orthodontic bonding materials are composite resins based on the bis-GMA formula. Although the use of these materials is well accepted, one major problem is the need for obtaining and maintaining a completely dry operating field throughout the bonding procedure .This is important because moisture contamination of the enamel surface is regarded as the commonest reason of bond failure. Bond failure of bracket retards treatment and is costly in terms of time, material and patient inconvenience. Hence, there was introduction of moisture resistant composite materials. The present study is designed to evaluate and compare the bond failure rate of Transbond MIP and Transbond XT as moisture insensitive and conventional materials respectively when used for direct bonding of orthodontic brackets.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
13.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.Permanent Dentition 2.Type of malocclusion including Class I, Class II & Class III 3.Adolescent or Adult Patients 4.Both Extraction and Non-Extraction Cases.

排除标准

  • 1.Teeth with facial/buccal restorations or Congenital defects 2.Teeth which are not fully erupted.
  • 3.Dentition with occlusal interferences and deep bite hindering proper bracket Positioning.
  • 4.Bracket failure caused by known operator error.
  • 5.Patient with previous orthodontic treatment.

结局指标

主要结局

BOND FAILURE RATE

时间窗: 6 months

次要结局

  • Adhesive Remnant Index(6 months)

研究者

发起方
Radheya Agrawal
申办方类型
Other [Self Funded]
责任方
Principal Investigator
主要研究者

Dr Radheya P Agrawal

Government Dental College and Hospital ,Cuddalore(erstwhile Rajah Muthiah Dental College)

研究点 (1)

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