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临床试验/CTRI/2024/04/065247
CTRI/2024/04/065247尚未招募3 期

Effectiveness of a novel “Visual Orientation through Integrated Color-coding and Enhancement” technique (VOICE) in improving the Oral hygiene status among adolescents with Hearing and Speech-Impairment: A Double-Blind Randomized Controlled Trial

Dr David Coutinho1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月15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
100
试验地点
1
主要终点
Gingival index, Plaque index

研究概览

简要总结

Hearing and Speech-Impaired Adolescents commonly struggle with maintaining oral health, which can result in an increased risk of oral health problems. Existing oral health education methods have demonstrated limited success in motivating behavior change among this age group. Thus, there is a pressing need to explore innovative approaches that effectively engage and motivate Hearing and Speech-Impaired Adolescents to improve their oral health. The study aims to address this need by evaluating the impact of a novel traffic light colour coded technique assisted with visual aids on enhancing oral health among Hearing and Speech-Impaired Adolescents

研究设计

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

入排标准

年龄范围
12.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • All children in the age group of 12 – 15 years having hearing loss of 70 dB or greater (severe hearing loss) with speech impairment.
  • All the index teeth should have completely erupted.

排除标准

  • Children with mild or moderate hearing loss.
  • Children with underlying systemic disease and/or other special health care needs conditions.
  • Children on medications.
  • Uncooperative children.
  • Parents and children not agreeing to give consent and assent.

结局指标

主要结局

Gingival index, Plaque index

时间窗: At Baseline and 3 months

次要结局

  • Knowledge and practices of Oral health(At baseline and end of 3 months)

研究者

发起方
Dr David Coutinho
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr David Coutinho

KAHERs KLE VK institute of dental sciences

研究点 (1)

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