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

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.

NCT Number	NCT07702383
Lead Sponsor	National University of Malaysia Collaborators: Universiti Sains Islam Malaysia, Universiti Teknologi Mara, International Islamic University Malaysia, Hasanuddin University
Conditions	Gingivitis, Gingivitis; Chronic
Enrollment	66 participants
Start Date	2026-09-01
Primary Completion	2027-04-28 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-15