NCT07702383Not yet recruiting
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
The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 28 Apr 2027
- Lead sponsor
- National University of Malaysia
- NCT number
- NCT07702383
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 1 Sept 2026 to the primary completion date, 28 Apr 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
Other illness
- Presence of systemic diseases known to influence oral and periodontal health
- Participants presenting with moderate - severe dentin hypersensitivity
- History of allergy or hypersensitivity to any material used in the study
- Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures
Other
- Using braces and dental prosthesis.
- Moderate or high dental caries risk
- Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
- Participants with mucosa/ gingival trauma/recession and tooth wear
- Pregnancy or breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to 24 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Dentistry, Universiti Kebangsaan Malaysia Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Faculty of Dentistry, Universiti Sains Islam Malaysia Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Kulliyyah of Dentistry, International Islamic University Malaysia Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| Faculty of Dentistry, Universiti Teknologi MARA Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.