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A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improving Short-term Periodontal Outcomes, Compliance, and Acceptability Among Clinical Dental Students
Sponsor: National University of Malaysia
Summary
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.
Official title: The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.
Key Details
Gender
All
Age Range
18 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-09-01
Completion Date
2027-05-31
Last Updated
2026-07-14
Healthy Volunteers
Yes
Conditions
Interventions
SMILE Module
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.
Conventional Toothbrushing Module
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.
Locations (4)
Faculty of Dentistry, Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
Faculty of Dentistry, Universiti Sains Islam Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
Kulliyyah of Dentistry, International Islamic University Malaysia
Kuantan, Pahang, Malaysia
Faculty of Dentistry, Universiti Teknologi MARA
Sungai Buloh, Selangor, Malaysia