NCT07584512

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 6, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Faith-Based Health PromotionPretest sensitizationSunnahCommunity HealthBangladesh;Solomon Four-Group DesignQuasi-ExperimentalHealth Belief ModelMiswakTooth BrushingOral Health EducationMosque-Based InterventionKhutbaseremon

Outcome Measures

Primary Outcomes (2)

  • Clinical Plaque Score (Reversed)

    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

    Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)

  • Oral Health Knowledge Score

    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.

    Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)

Secondary Outcomes (1)

  • Self-Reported Tooth Brushing Practice Score

    Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)

Study Arms (4)

Arm 1 (E1): Intervention + Pretest

EXPERIMENTAL

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.

Behavioral: Smile With Prophet (SWP)

Arm 2 (E2): Intervention Only (No Pretest)

EXPERIMENTAL

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.

Behavioral: Smile With Prophet (SWP)

Arm 3 (C1): Control with Pretest

NO INTERVENTION

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.

Arm 4 (C2): Control Only (No Pretest)

NO INTERVENTION

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.

Interventions

"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

Arm 1 (E1): Intervention + PretestArm 2 (E2): Intervention Only (No Pretest)

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Masjid As Siddique (RA)

Dhaka, 1217, Bangladesh

Location

Angarzora Ahli Hadeeth Jame Masjid

Dhaka, 1219, Bangladesh

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: In this Solomon four-group design, participants were allocated to four groups: intervention and control, each with pretest-posttest and posttest-only arms. Two similar mosques were selected conveniently. Within each site, participants were randomly assigned (pseudo-randomisation). Pretesting was conducted in one intervention and one control group. Baseline data were collected during the first Friday congregation, prior to a 15-minute sermon. A miswak was provided after clinical assessment. A reinforcement session (second 15-minute khutba) and distribution of educational leaflets were conducted during the second Friday. A soft-bristled toothbrush was given at this time as an intervention and attendance tracker. Final follow-up assessments (questionnaire and clinical examination) were conducted during the third Friday. The intervention mosque phase ran from 23 September to 7 October 2022. The control mosque phase ran from 14 October to 28 October 2022. Each phase lasted 3 weeks. Attend
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 13, 2026

Study Start

September 23, 2022

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations