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临床试验/CTRI/2025/05/086536
CTRI/2025/05/086536尚未招募3 期

A comparative evaluation of orthodontic molar band retention with and without microetching: A Randomized Controlled Trial

Jay Thakkar1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Number and type of band failure

研究概览

简要总结

AIM

·        The aim of the present study was to investigate retention and stability of micro-etched molar bands and conventional molar bands in a prospective, randomized, controlled trial.

MATERIALS AND METHODOLOGY

This study with a split-mouth design will be conducted  in the Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University, Nadiad, Gujarat.

A total of 75 patients resulting in a total of 300 molar bands cemented, which included 150 micro-etched bands and 150 conventional bands with side allocation determined through Block Randomization.

Band retention will be checked at 4-week intervals, and loose bands will be deemed as failures. The date of failure will be recorded as accurately as possible; if not identifiable, the date of the patient’s department visit will be noted.

The study will track all cases either to the end of treatment or a maximum period of 1 year and 6 months (540 days), after which molar bands will be censored for patients whose bands have not failed.

STATISTICAL ANALYSIS

The statistical analysis was conducted using Chi-Square test using SPSS 8.0 to evaluate the influence of various explanatory variables on band failure.

Failure rates of microetched and conventional bands are compared amongst subjects and among bands.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • •Patients receiving fixed appliance treatment.
  • •Treatment involving the cementation of at least one pair of bands on first permanent molar teeth in the same arch.

排除标准

  • •Patients in which the treatment plan includes the first permanent molar in their appliance design.
  • •Patient having primary dentition Partially erupted any Permanent first molar maxilla and mandible Grossly decayed any Permanent first molar maxilla and mandible Patients with cleft lip and palate and Syndromes.

结局指标

主要结局

Number and type of band failure

时间窗: 4 weeks for 18 months

次要结局

  • •To assess the survival times of micro-etched molar bands in relation to conventional molar bands.(4 weeks for 18 months)

研究者

发起方
Jay Thakkar
申办方类型
Other [self]

研究点 (1)

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