- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07584512
Mosque-based Oral Health Intervention Using Solomon Design
"Health Education Intervention on Tooth Brushing Among the Mosque Attendees
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dhaka, 방글라데시, 1217
- Masjid As Siddique (RA)
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Dhaka, 방글라데시, 1219
- Angarzora Ahli Hadeeth Jame Masjid
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Respondent is willing to participate and gives consent.
- Respondent is aged 18 years or older.
- Respondent attends weekly congregation prayers at the selected mosque.
Exclusion Criteria:
• Respondent is mentally unstable or unable to understand the intervention (e.g., too old or cognitively impaired).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Arm 1 (E1): Intervention + Pretest
Participants receive the SWP (Smile With Prophet) oral health education intervention plus a pretest assessment.
The intervention includes: (1) oral health education delivered via Friday sermon (khutba) integrating Islamic teachings on hygiene; (2) distribution of educational leaflet; (3) provision of miswak; (4) dental health campaign with clinical examination.
Pretest (baseline) includes questionnaire (knowledge, practice) and clinical plaque assessment.
Posttest is conducted at 3-week follow-up.
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"Smile With the Prophet (pbuh)" (SWP) intervention is an intervention specially designed for this intervention study. Composed of the following: Khutba: 15-minute Friday sermon (khutba) delivered by the Imam, integrating evidence-based oral health messages with Islamic teachings on hygiene (Sunnah); each supported by several Qur'an verses (ayah), or Islamic faith-based decrees. The messages were developed through consultation involving Advisory Committee board consisting of Islamic scholars and public health professionals. Booklet: A 4-page illustrated educational leaflet on proper tooth brushing technique and use of miswak, available in Bengali; Miswak & Toothbrush :Provision of a miswak (traditional tooth cleaning stick) and a soft-bristled toothbrush |
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실험적: Arm 2 (E2): Intervention Only (No Pretest)
Participants receive the SWP (Smile With Prophet) oral health education intervention but do not undergo pretest assessment.
The intervention includes: (1) oral health education delivered via Friday sermon (khutba) integrating Islamic teachings on hygiene; (2) distribution of educational leaflet; (3) provision of miswak; (4) dental health campaign with clinical examination.
Posttest only is conducted at 3-week follow-up.
|
"Smile With the Prophet (pbuh)" (SWP) intervention is an intervention specially designed for this intervention study. Composed of the following: Khutba: 15-minute Friday sermon (khutba) delivered by the Imam, integrating evidence-based oral health messages with Islamic teachings on hygiene (Sunnah); each supported by several Qur'an verses (ayah), or Islamic faith-based decrees. The messages were developed through consultation involving Advisory Committee board consisting of Islamic scholars and public health professionals. Booklet: A 4-page illustrated educational leaflet on proper tooth brushing technique and use of miswak, available in Bengali; Miswak & Toothbrush :Provision of a miswak (traditional tooth cleaning stick) and a soft-bristled toothbrush |
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간섭 없음: Arm 3 (C1): Control with Pretest
Participants receive no oral health education intervention.
They undergo pretest assessment (baseline questionnaire and clinical plaque examination) and posttest assessment at 3-week follow-up.
This arm controls for pretest sensitisation effects.
After study completion, participants received the SWP intervention.
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간섭 없음: Arm 4 (C2): Control Only (No Pretest)
Participants receive no oral health education intervention and do not undergo pretest assessment.
They undergo posttest only at 3-week follow-up.
This arm controls for both pretest sensitisation and temporal trends.
After study completion, participants received the SWP intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Plaque Score (Reversed)
기간: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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Objective clinical measure of oral hygiene.
Assessed using the Greene-Vermillion Simplified Oral Hygiene Index (reversed).
Dental examiner evaluates plaque thickness along the gingival margin on four surfaces (distal, facial, mesial, lingual) of each tooth.
Reversed score range 0-3.
Higher reversed score indicates less plaque and better oral hygiene.
This is the primary evidence of behavior change
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Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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Oral Health Knowledge Score
기간: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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Measured using a 14-item self-administered questionnaire assessing understanding of oral hygiene, tooth brushing frequency, miswak use, dietary effects on teeth, and gum health.
Each correct answer scores 1 point.
Total score range 0-14.
Higher score indicates better knowledge.
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Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Self-Reported Tooth Brushing Practice Score
기간: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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Subjective self-report measure.
Assessed using a 15-item questionnaire on tooth brushing frequency, duration, technique, coverage of tooth surfaces, and miswak use.
Each appropriate practice scores 1 point.
Range 0-15.
Higher score indicates better self-reported practices.
Subject to recall and social desirability bias.
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Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- NIPSOM/IRB/2017/09
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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