- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
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Dhaka, Bangladesch, 1217
- Masjid As Siddique (RA)
-
Dhaka, Bangladesch, 1219
- Angarzora Ahli Hadeeth Jame Masjid
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
"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 |
|
Experimental: 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 |
|
Kein Eingriff: 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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Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical Plaque Score (Reversed)
Zeitfenster: 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)
|
|
Oral Health Knowledge Score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-Reported Tooth Brushing Practice Score
Zeitfenster: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
|
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.
|
Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- NIPSOM/IRB/2017/09
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