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.
Adults aged 18 - 24 years
Clinical dental students enrolled at one of the participating universities.
Participants with a maximum diagnosed with plaque-induced gingivitis according to the 2018 Classification of Periodontal and Peri-Implant Diseases and Conditions, without clinical attachment loss attributable to periodontitis.
Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)
Using braces and dental prosthesis.
Presence of systemic diseases known to influence oral and periodontal health
Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
Moderate or high dental caries risk
Parallel
SMILE Module
BehavioralThe 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.
Conventional Toothbrushing Module
BehavioralParticipants 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.
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.
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.
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National University of Malaysia
Lead sponsor
Universiti Sains Islam Malaysia
Collaborator
Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia
Collaborator
International Islamic University Malaysia
Collaborator
Hasanuddin University
Collaborator
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