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| Name | Class |
|---|---|
| Universiti Sains Islam Malaysia | OTHER |
| Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia | UNKNOWN |
| International Islamic University Malaysia | OTHER |
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This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Conventional toothbrushing will serve as the control intervention.
Eligible participants will be randomly assigned to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive professional oral prophylaxis, standardised oral hygiene education, structured training according to their allocated intervention, and digital monitoring throughout the 21-day study period.
The study will assess changes in plaque accumulation, gingival health, and bleeding on probing, as well as participant compliance, behavioural outcomes, acceptability of the SMILE module, and intervention-related adverse events.
It is hypothesised that the SMILE module will effectively improve short-term periodontal outcomes, promote better compliance with the recommended oral hygiene practice, and achieve favourable acceptability while maintaining participant safety.
The participants will be recruited from four Malaysian universities and two Indonesian universities. Individuals who meet the eligibility criteria and provide written informed consent will undergo screening, oral examination, professional oral prophylaxis and any necessary dental treatment to establish a comparable baseline oral condition prior to randomisation.
Participants will then be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group using a computer-generated stratified randomisation sequence. Allocation concealment will be maintained through a centralised electronic allocation system. Outcome assessors and data analysts will remain blinded to group allocation.
The SMILE intervention group will receive a structured behavioural module delivered through the SMILE mobile application. The programme includes standardised instruction on siwak preparation, brushing technique, storage, recommended frequency of use, instructional videos, supervised hands-on practice, a standardised siwak kit, and daily monitoring using the mobile application with a paper logbook available as a contingency.
Participants in the control group will receive a structured conventional toothbrushing module following the same training schedule and monitoring procedures. A standardised toothbrush kit and the study application containing toothbrushing educational materials will be provided to ensure equivalent participant support and follow-up throughout the study.
Following completion of training, participants will perform their allocated oral hygiene practice for 21 consecutive days. Adherence to the assigned intervention will be monitored using the study application or the paper logbook when required. Clinical assessments will be conducted at baseline and at Day 21 by calibrated examiners using standardised periodontal examination procedures. The study is designed to determine the efficacy of the SMILE module under controlled conditions using conventional toothbrushing as the active control intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMILE Intervention Group | Experimental | Participants assigned to this group will receive the SMILE module behavioural intervention. The intervention includes standardised training in integrated siwak practice delivered through a mobile application, supervised hands-on practice, a standardised siwak kit, daily compliance monitoring, and supporting educational materials. Participants will perform integrated siwak practice according to the standardised protocol for 21 consecutive days. |
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| Conventional Toothbrushing Control Group | Active Comparator | Participants assigned to this group will receive standardised oral hygiene education based on conventional toothbrushing. They will undergo the same recruitment procedures, oral examination, prophylaxis, training duration, monitoring schedule, follow-up assessments, and data collection procedures as the intervention group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMILE Module | Behavioral | The SMILE module intervention is a standardised behavioural oral hygiene programme designed to promote appropriate siwak use. The programme includes instruction on siwak preparation, brushing techniques, storage, replacement, frequency of use, and monitoring for safe siwak practice. Training is delivered through the SMILE mobile application using instructional videos and structured educational content, followed by supervised practical training. Participants will receive a standardised siwak kit and will be instructed to perform siwak cleaning five times daily, corresponding to the recommended practice incorporated within the module. Adherence will be monitored throughout the 21-day intervention using the mobile application and/or daily logbook. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plaque Index (PI) | Plaque accumulation will be assessed using the Silness and Löe Plaque Index (1964), which evaluates the amount of plaque present at the gingival margin on four tooth surfaces using a 0-3 ordinal scale. Lower scores indicate better plaque control. | Baseline (day 0) and day 21 after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Index (GI) | Gingival inflammation will be assessed using the Löe and Silness Gingival Index (1963), which evaluates gingival colour, consistency, and bleeding on gentle probing on a 0-3 ordinal scale. Lower scores indicate healthier gingival conditions. | Baseline (day 0) and day 21 after randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanah Pertiwisari, drg, M.KG | Contact | +60 10-5871-889 | p154143@siswa.ukm.edu.my | |
| Shahida Mohd Said, BDS, MClinDent (Periodontology | Contact | shahidams@ukm.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Universiti Kebangsaan Malaysia | Kuala Lumpur | Kuala Lumpur | 50300 | Malaysia |
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| Hasanuddin University |
| OTHER |
Participants will be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive the same study procedures, including professional oral prophylaxis, standardised oral hygiene education, structured training delivered through a dedicated mobile application, and identical monitoring throughout the 21-day intervention period. The intervention differs only in the oral hygiene tool and the intervention-specific training provided. Outcomes will be assessed at baseline and Day 21 using standardised clinical assessment procedures.
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Due to the nature of the behavioural intervention, participants, care providers, and investigators cannot be blinded to group allocation. However, outcome assessors responsible for the clinical examinations will remain blinded to treatment allocation. The examiners will not be involved in participant training or intervention delivery, and participants will be instructed not to disclose their allocated intervention during clinical assessments. Statistical analyses will be performed using anonymised datasets with coded treatment groups by an independent data analyst who will remain blinded to treatment allocation until completion of the primary analyses.
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| Conventional Toothbrushing Module | Behavioral | Participants will receive standardised training in conventional toothbrushing through a structured educational module delivered using the study mobile application. The programme includes instruction on toothbrush preparation, brushing techniques, brushing duration, and toothbrush replacement recommendations. Participants will receive a standardised toothbrush kit and will be instructed to brush their teeth twice daily for approximately two minutes throughout the 21-day intervention period. Compliance will be monitored using mobile application and daily logbook employed for the intervention group. |
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| Faculty of Dentistry, Universiti Sains Islam Malaysia | Kuala Lumpur | Kuala Lumpur | 55100 | Malaysia |
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| Kulliyyah of Dentistry, International Islamic University Malaysia | Kuantan | Pahang | 25200 | Malaysia |
| Faculty of Dentistry, Universiti Teknologi MARA | Sungai Buloh | Selangor | 47000 | Malaysia |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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