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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-24
SponsorNational University of Malaysia

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SMILE Module
  • Conventional Toothbrushing Module

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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