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临床试验/CTRI/2024/11/077024
CTRI/2024/11/077024进行中(未招募)不适用

Effectiveness of foam tooth brush on oral health status of children with Attention Deficit Hyperactivity Disorder - A Randomized Controlled Trial

The Tamilnadu Dr.MGR Medical University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月29日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
70
试验地点
1
主要终点
To compare the effectiveness of foam tooth brush and conventional tooth brush on oral health status of children with ADHD.

研究概览

简要总结

NULL HYPOTHESIS

There is no difference between the effectiveness of foam toothbrush and conventional toothbrush on oral health status of children with ADHD.

Method:

Oral prophylaxis will be done and oral health education will be given to the children with ADHD one week before the intervention. Baseline Visual Plaque Index (VPI) scores (Silness and Loe, 1967), and Gingival Bleeding Index (GBI) scores (Loe and Silness, 1963) will be recorded in four tooth surfaces (buccal / facial, lingual, mesio-buccal, disto-buccal surfaces) of all teeth using mouth mirror and explorer two days after the oral prophylaxis. Disclosing agent (Alpha Plac) will be used before the examination. Children will be divided into 2 subtypes - Attention-deficit as group 1 and Hyperactive and Impulsivity as group 2 based on parents response for ADHD rating score. Each subtype will be further randomly allocated into two subgroups. Subgroup 1 will be given conventional toothbrushes (Colgate soft tooth brush) and subgroup 2 will be given foam toothbrushes (Colgate ultrafoam ultrasoft toothbrush). A specific fluoridated toothpaste will be provided to all the children, to use during the three month study period.  Proper brushing instructions and IDA approved toothpastes (Colgate) will be given to the children. Post-intervention data (VPI, GBI scores) will be recorded after 15 days, 1 month and 3 months and wear assessment of the toothbrushwill be done after 3months and data will be statistical analyzed.

研究设计

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

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Healthy children and their parents who were able to read and respond to a questionnaire.

排除标准

  • Children with systemic illness, other medical conditions and parents who could not read and respond to a questionnaire will be excluded.

结局指标

主要结局

To compare the effectiveness of foam tooth brush and conventional tooth brush on oral health status of children with ADHD.

时间窗: Baseline, 15 days, 1 month, 3 months

次要结局

  • To compare the toothbrush wear of foam tooth brush and conventional tooth brush on oral health status of children with ADHD.(Baseline, 15 days, 1 month, 3 months)

研究者

发起方
The Tamilnadu Dr.MGR Medical University
申办方类型
Other [Medical University]
责任方
Principal Investigator
主要研究者

Yazhini Selvaraj

KSR Institute of Dental Science and Research

研究点 (1)

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