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临床试验/NCT07584512
NCT07584512已完成不适用

"Health Education Intervention on Tooth Brushing Among the Mosque Attendees

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2022年9月23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
142
试验地点
2

研究概览

简要总结

This quasi-experimental study evaluates a mosque-based oral health education intervention ("Smile With Prophet", SWP) among adult male mosque attendees in Dhaka, Bangladesh, using a Solomon four-group design.

A total of 142 participants were enrolled across two mosques (intervention and control). The analytical sample comprises 80 adult male attendees (≥18 years) allocated to four groups: intervention and control, each with pretest-posttest and posttest-only arms (n=20 per group).

The SWP intervention consists of oral health education delivered through Friday sermons (khutbas), supported by educational leaflets and provision of miswak. Outcomes are measured at baseline and 3-week follow-up and include oral health knowledge (14-item questionnaire), self-reported tooth brushing practices (15-item questionnaire), and clinical plaque scores (Greene-Vermillion Simplified Oral Hygiene Index, reversed).

The primary objective is to evaluate the effect of the intervention on knowledge and plaque scores. The secondary objective is to assess self-reported practice changes.

详细描述

Study design: Quasi-experimental study using a Solomon four-group design conducted in two mosques in Dhaka, Bangladesh, between January and December 2022.

Participants: A total of 142 adult male mosque attendees (≥18 years) who attended three consecutive Friday congregational prayers were enrolled. Of these, 119 completed baseline assessment (pretest questionnaire and clinical plaque examination). Across the three-week study period, 80 participants completed all required follow-up assessments and are included in the final analysis (40 intervention, 40 control). Participants were allocated to four groups: intervention and control, each with pretest-posttest and posttest-only arms (n=20 per subgroup).

Intervention: The "Smile With Prophet" (SWP) intervention comprises: (1) oral health education delivered through Friday sermons (khutbas) integrating scientific evidence with Islamic teachings (Sunnah); (2) educational leaflets for take-home reinforcement; (3) provision of miswak (traditional tooth cleaning stick); and (4) a dental health campaign with clinical examination. The control group receives standard khutbas without oral health content; the intervention is provided after study completion.

Statistical analysis

Non-parametric tests will be used for data that are not normally distributed (Kolmogorov-Smirnov test). Mann-Whitney U tests will compare groups; Wilcoxon signed-rank tests will assess within-group changes; Kruskal-Wallis tests will compare all four Solomon groups simultaneously. The Solomon four-group design controls for pretest sensitisation. Attrition analysis will compare baseline characteristics of retained versus lost participants.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

3.12.1 Hiring Doctors: None of the doctors were used for second time for data collection campaigns to avoid examiners bias. A total of 10 doctors are hired for four dental check-up (pre and post test in intervention & control mosques).

But they were not informed about the objectives of the study and whether the mosque was an intervention or control mosque, or whether the campaign was baseline data collection or for follow up data

3.2.1 Mosque Agreement: Written informed consent was obtained from heads of the mosque Committees or from imams or khatibs for their and their mosques' participation after describing required data collection procedures (without disclosing the desired objectives hypothesis of the study thus masking the intention)

• Privacy and confidentiality were maintained strictly, as each of the participants was assessed separately and the dentist examined the participants with in a screened compartment of the mosque.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Respondent is willing to participate and gives consent.
  • Respondent is aged 18 years or older.
  • Respondent attends weekly congregation prayers at the selected mosque.

排除标准

  • Respondent is mentally unstable or unable to understand the intervention (e.g., too old or cognitively impaired).

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tasnim Shahriar Osama

Principal Investigator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (2)

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