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 (SMILE)

July 13, 2026 updated by: Nik Madihah Nik Aziz, National University of Malaysia

The Efficacy of Integrated Siwak Practice (SMILE) Module on Short-term Periodontal Clinical Outcome, Compliance, and Acceptance.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants will be recruited from four Malaysian universities and two Indonesian universities. Individuals who meet the eligibility criteria and provide written informed consent will undergo screening, oral examination, professional oral prophylaxis and any necessary dental treatment to establish a comparable baseline oral condition prior to randomisation.

Participants will then be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group using a computer-generated stratified randomisation sequence. Allocation concealment will be maintained through a centralised electronic allocation system. Outcome assessors and data analysts will remain blinded to group allocation.

The SMILE intervention group will receive a structured behavioural module delivered through the SMILE mobile application. The programme includes standardised instruction on siwak preparation, brushing technique, storage, recommended frequency of use, instructional videos, supervised hands-on practice, a standardised siwak kit, and daily monitoring using the mobile application with a paper logbook available as a contingency.

Participants in the control group will receive a structured conventional toothbrushing module following the same training schedule and monitoring procedures. A standardised toothbrush kit and the study application containing toothbrushing educational materials will be provided to ensure equivalent participant support and follow-up throughout the study.

Following completion of training, participants will perform their allocated oral hygiene practice for 21 consecutive days. Adherence to the assigned intervention will be monitored using the study application or the paper logbook when required. Clinical assessments will be conducted at baseline and at Day 21 by calibrated examiners using standardised periodontal examination procedures. The study is designed to determine the efficacy of the SMILE module under controlled conditions using conventional toothbrushing as the active control intervention.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50300
        • Faculty of Dentistry, Universiti Kebangsaan Malaysia
        • Contact:
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 55100
        • Faculty of Dentistry, Universiti Sains Islam Malaysia
        • Contact:
    • Pahang
      • Kuantan, Pahang, Malaysia, 25200
        • Kulliyyah of Dentistry, International Islamic University Malaysia
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Faculty of Dentistry, Universiti Teknologi MARA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 18 - 24 years
  2. Clinical dental students enrolled at one of the participating universities.
  3. 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.
  4. Have adequate oral hygiene (ranging from good to fair; score from 0 to 1.9 according to Silness and Löe plaque index (1964)
  5. Possess at least 28 natural teeth.
  6. Able to understand study procedures and provide written informed consent.
  7. Willing to comply with all study procedures, intervention instructions, and follow-up assessments.

Exclusion Criteria:

  1. Using braces and dental prosthesis.
  2. Presence of systemic diseases known to influence oral and periodontal health
  3. Use of antibiotics for the last 3 months or any medication or known to affect oral and periodontal tissues or salivary flow
  4. Moderate or high dental caries risk
  5. Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
  6. Participants presenting with moderate - severe dentin hypersensitivity
  7. Participants with mucosa/ gingival trauma/recession and tooth wear
  8. Pregnancy or breastfeeding
  9. History of allergy or hypersensitivity to any material used in the study
  10. Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMILE Intervention Group
Participants assigned to this group will receive the SMILE module behavioural intervention. The intervention includes standardised training in integrated siwak practice delivered through a mobile application, supervised hands-on practice, a standardised siwak kit, daily compliance monitoring, and supporting educational materials. Participants will perform integrated siwak practice according to the standardised protocol for 21 consecutive days.
Behavioral: 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.
Active Comparator: Conventional Toothbrushing Control Group
Participants assigned to this group will receive standardised oral hygiene education based on conventional toothbrushing. They will undergo the same recruitment procedures, oral examination, prophylaxis, training duration, monitoring schedule, follow-up assessments, and data collection procedures as the intervention group.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plaque Index (PI)
Time Frame: Baseline (day 0) and day 21 after randomisation
Plaque accumulation will be assessed using the Silness and Löe Plaque Index (1964), which evaluates the amount of plaque present at the gingival margin on four tooth surfaces using a 0-3 ordinal scale. Lower scores indicate better plaque control.
Baseline (day 0) and day 21 after randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gingival Index (GI)
Time Frame: Baseline (day 0) and day 21 after randomisation
Gingival inflammation will be assessed using the Löe and Silness Gingival Index (1963), which evaluates gingival colour, consistency, and bleeding on gentle probing on a 0-3 ordinal scale. Lower scores indicate healthier gingival conditions.
Baseline (day 0) and day 21 after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Collaborators

Universiti Sains Islam Malaysia
Hasanuddin University
International Islamic University Malaysia
Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DD-2026-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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