A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improv… (NCT07702383) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Malaysia66 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. Possess at least 28 natural teeth.
. Able to understand study procedures and provide written informed consent.
. Willing to comply with all study procedures, intervention instructions, and follow-up assessments.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a training module called SMILE™ aimed at dental students — does that mean my care would be provided by students learning a new technique, and how might that affect the quality of treatment I receive?
2The trial hasn't started recruiting yet — given that my gingivitis needs attention now, is it worth waiting to see if I'm eligible, or should I begin standard treatment right away?
3The main thing this study is measuring is a Plaque Index score — does that mean the focus is more on evaluating the students' training outcomes than on improving my specific gum health, and how should I weigh that?
4Since this is a randomised trial, is there a chance I could be assigned to a group that doesn't receive the SMILE™ module, and would both groups still receive care that meets the standard of treatment for chronic gingivitis?
5Are there proven treatments for gingivitis I should consider first before looking into a trial that is primarily designed to evaluate a dental education tool rather than a new patient therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Plaque Index (PI)
Timeframe: Baseline (day 0) and day 21 after randomisation