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临床试验/CTRI/2020/03/024391
CTRI/2020/03/024391已完成2/3 期

Efficacy of remineralising agents on white spots lesions during fixed orthodontic treatment- a controlled clinical trial

Priyanka choudhary1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月4日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
to determine the effects of remineralising agents on white spots lesions.

研究概览

简要总结

The study was conducted to determine the efficacy of three different re-mineralising agents on white spots lesions during fixed orthodontic treatment as evaluated using Digital and Visual examination method. In the study, WSLs adjacent to the orthodontic bracket were treated and monitored for a period of 6 months in adolescents who were undergoing orthodontic treatment. Young adults were selected for the study as they can follow the given instructions for using the re-mineralising agents. The total sample included in this study was 86 based on 2 methods i.e. visual examination (ICDAS II Criteria) and digital method (DIAGNODent pen). Teeth without any sign of active white spot lesions i.e. score 5 and 6 on the ICDAS scale, were excluded from the study. Teeth with a score of 2 to 4 on the labial surface as per ICDAS II criteria were selected and further assesed using DIAGNODent pen (Kavo, Germany). Teeth with a score of 0-10 when assesed using a DIAGNODent pen in the labial surface were finally selected.

The selected samples were further randomly into 4 groups- Group 1- Control group, Group 2- MI Varnish, Group 3- Clinpro creme and Group 4- Toothmin toothpaste. all the selected patients were educated and motivate to use the fluoride toothpaste (Colgate Total; 1000 ppm F) two times a day during the study period of 6 months. for patients in MI Varnish group, in-office application of varnish was done at T0. Group 3 and 4 patients were informed to use the respective re-mineralising agents two times a day during the study period of 6 months. Every patients was monitored every month and patients were asked to submit empty tubes of remineralising agents.

Patients were assesed using standard loupes for visual examination and using Diagnodent for digital examination at two intervals i.e. at T0 (at baseline) and T1( after 6 months).

In all the groups, the mean ICDAS II and DIAGNODent scores decreased from baseline (T0) to after 6 months reevaluation (T1) which confirms the efficacy of remineralization agents on the WSLs.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
13.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • no previous fixed orthodontic treatment.
  • permanent dentition.
  • fully erupted anterior teeth.
  • first two month of fixed appliance therapy.
  • no smoking habits.

排除标准

  • patients with systemic problems.
  • enamel hypoplasia.
  • dental fluorosis.
  • intrinsic and extrinsic pigmentation.
  • periodontal problems.

结局指标

主要结局

to determine the effects of remineralising agents on white spots lesions.

时间窗: at 5 month and 8 month after bonding

次要结局

  • to compare the effect of various remileralising agents on reduction of white spot lesions.(at 5 month and 8 month after bonding)

研究者

发起方
Priyanka choudhary
申办方类型
Other [self]

研究点 (1)

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