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临床试验/CTRI/2021/10/037053
CTRI/2021/10/037053已完成不适用

Effectiveness of plaque removal using different toothbrushes in children – a randomized controlled clinical trial

OBUKAVITHA D1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年4月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
To assess and compare the effectiveness of plaque removal using three different toothbrushes.

研究概览

简要总结

The effectiveness of different types of toothbrushes on plaque removal in 6 to 8-year school-going children will be assessed using the Turesky modification of Quigley and Hein Index. After getting permission from schools, screening of school children for population selection. Children were selected based on the inclusion criteria. Only children had dmft score less than or equal to 2 and children should not use any of the study toothbrushes for oral hygiene measures. 75 children were included after getting informed consent from their parents. Baseline data were evaluated after one week of oral prophylaxis. 75 children were randomly allocated to 3 groups. Group I were received conventional toothbrushes; Group II were received powered toothbrushes; Group III were received MagiK interactive toothbrushes. Post intervention data collection was done at 15th day, 30th day, 45th day and finally 90th day. Data collected were plaque score, toothbrush wear and bite mark score according to the criteria given by corforti et al in 2003. Patient preferred toothbrush were evaluated by distributing the questionnaire at 90th day follow up. Data collected were subjected to statistical analysis

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Physically and mentally healthy children -Subjects who have never used any of the toothbrushes included in the study -Children who are not using any other oral hygiene aids -Children willing to participate in the study -Children with a minimum of 16 teeth in their oral cavity.

排除标准

  • Children with gingival/periodontal diseases and/ or oral ulcers -Any physical condition that limits manual dexterity required for toothbrushing -History of medications for the past 3 months that could affect the oral health -Patient wearing fixed orthodontic appliances, removable dentures.

结局指标

主要结局

To assess and compare the effectiveness of plaque removal using three different toothbrushes.

时间窗: 3 and 6 months follow-up.

次要结局

  • To assess the degree of wear and distribution of bite mark in 3 toothbrushes.(3 months)
  • Patient acceptance of toothbrushes.(6 months)

研究者

发起方
OBUKAVITHA D
申办方类型
Other [Self sponsor]

研究点 (1)

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