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临床试验/CTRI/2025/09/094530
CTRI/2025/09/094530尚未招募4 期

Effect of Brief Action Planning intervention on oral health behaviours of adolescents A randomised controlled study

King George Medical University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
122
试验地点
1
主要终点
Caries increment as assessed by

研究概览

简要总结

This randomized controlled study will assess the effectiveness of Motivational Interviewing with Brief Action Planning  MI BAP versus conventional health education in improving oral health behaviours of adolescents aged 10 14 years The primary outcomes include sustained toothbrushing behaviour caries increment  plaque score sweet score and oral health confidence Secondary outcomes involve correlations between dietary behaviours caries activity and plaque accumulation Eligibility adolescents aged 10 14 years with moderate high caries risk plaque scores 1 2 sugar score greater than and equal to 10 able to read and write English or Hindi and without systemic or psychiatric disorders Conclusion MI BAP offers a structured patient centred approach with minimal risk and potential long term behavioural benefits

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • 1 Adolescents in the age group of 10 to 14 years.
  • 2 Adolescents whose sugar consumption score is more than equal to 10 3 Adolescents whose Silness and Loe plaque scores between 1 and 2 4 Adolescents who have a moderate to high likelihood of caries development as determined using ICCMS International Caries Classification and management system 4 Adolescents who are able to read, write and understand in English or Hindi 5 Adolescents who are not diagnosed with behavioural disorders assessed using Child Behaviour Checklist.

排除标准

  • 1 Adolescents with any systemic conditions impacting oral health.
  • 2 Adolescents who are un cooperative to OHRBS due to any reason.
  • 3 Adolescents with any diagnosable psychiatric disorder.
  • • Adolescents with any intellectual disability in clinical assessment.

结局指标

主要结局

Caries increment as assessed by

时间窗: Baseline, 1 month, 3 months, 6 months

1 number of new carious lesions,

时间窗: Baseline, 1 month, 3 months, 6 months

2 number of progressed lesions,

时间窗: Baseline, 1 month, 3 months, 6 months

3 change in number of active/inactive lesions

时间窗: Baseline, 1 month, 3 months, 6 months

次要结局

  • Change in plaque score(Baseline, 1 month, 3 months, 6 months)
  • Change in sweet score(Baseline, 1 month, 3 months, 6 months)
  • Oral health confidence score(6 months)
  • Correlation of caries increment plaque scores with sweet scores Oral health confidence scores & self reported OHRB(6 months)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sindhuja Arunachalam

King George Medical University

研究点 (1)

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