Dental Plaque AccumulationNCT07584512
Mosque-based Oral Health Intervention Using Solomon Design
A study testing Smile With Prophet (SWP) in people with Dental Plaque Accumulation and Oral Hygiene Education, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 2 sites in Bangladesh.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque Accumulation, Oral Hygiene Education
- What is being tested?
- Smile With Prophet (SWP)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesBangladesh
- Study dates
- 23 Sep 2022to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Respondent is willing to participate and gives consent.
- Respondent is aged 18 years or older.
- Respondent attends weekly congregation prayers at the selected mosque.
Who cannot join
- Respondent is mentally unstable or unable to understand the intervention (e.g., too old or cognitively impaired).
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Masjid As Siddique (RA)
Dhaka, 1217
Angarzora Ahli Hadeeth Jame Masjid
Dhaka, 1219
About this study
Official title: "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).
Read more
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.
Read the detailed description
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.
- Conditions
- Dental Plaque Accumulation, Oral Hygiene Education
- Being tested
- Smile With Prophet (SWP)
- Keywords
- Faith-Based Health Promotion, Pretest sensitization, Sunnah, Community Health, Bangladesh;, Solomon Four-Group Design, Quasi-Experimental, Health Belief Model, Miswak, Tooth Brushing, Oral Health Education, Mosque-Based Intervention, Khutba, seremon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smile With Prophet (SWP)Behavioural
"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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
Secondary outcomes (1)
Self-Reported Tooth Brushing Practice Score
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.
Measured: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start23 Sep 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque AccumulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasnim Shahriar Osama, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584512
- Sponsor's protocol ID
- NIPSOM/IRB/2017/09
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Health Education Intervention on Tooth Brushing Among the Mosque Attendees
- ClinicalTrials.gov ID
- NCT07584512
- Acronym / sponsor ID
- NIPSOM/IRB/2017/09
- Conditions
- Dental Plaque Accumulation, Oral Hygiene Education
- Keywords
- Faith-Based Health Promotion, Pretest sensitization, Sunnah, Community Health, Bangladesh;, Solomon Four-Group Design, Quasi-Experimental, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (E1): Intervention + Pretest | Experimental | Behavioral: Smile With Prophet (SWP)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. |
| Arm 2 (E2): Intervention Only (No Pretest) | Experimental | Behavioral: Smile With Prophet (SWP)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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Respondent is willing to participate and gives consent.
- Respondent is aged 18 years or older.
- Respondent attends weekly congregation prayers at the selected mosque.
Key exclusion criteria (1 listed)
- Respondent is mentally unstable or unable to understand the intervention (e.g., too old or cognitively impaired).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smile With Prophet (SWP)"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 | Behavioural | Arm 1 (E1): Intervention + Pretest, Arm 2 (E2): Intervention Only (No Pretest) |
Primary outcome
Clinical Plaque Score (Reversed)
Time frame: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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
Oral Health Knowledge Score
Time frame: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
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.
1 secondary outcome
Self-Reported Tooth Brushing Practice Score
Time frame: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smile With Prophet (SWP) in people with Dental Plaque Accumulation and Oral Hygiene Education, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 2 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Plaque Score (Reversed) (time frame: Baseline (Week 1, pretested groups only) and 3-week follow-up (Week 3, all groups)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.