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

NCT07702383 | Not Yet Recruiting

• 1 other identifier: DD-2026-013
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Gingivitis; Gingivitis; Chronic

Keywords

salvadora persica; siwak; miswak; Behavioural intervention; Randomised controlled trial,; oral hygiene; gingivitis; prevention; periodontal health

Outcome Measures

Primary Outcomes (1)

• Change in Plaque Index (PI)

  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 Outcomes (1)

• Change in Gingival Index (GI)

  Baseline (day 0) and day 21 after randomisation

Study Arms (2)

SMILE Intervention Group

EXPERIMENTAL

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

Conventional Toothbrushing Control Group

ACTIVE COMPARATOR

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

Interventions

SMILE Module BEHAVIORAL

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.

SMILE Intervention Group

Conventional Toothbrushing Module BEHAVIORAL

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.

Conventional Toothbrushing Control Group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Severe tooth malposition that may interfere with plaque assessment or oral hygiene procedures
• Participants presenting with moderate - severe dentin hypersensitivity
• Participants with mucosa/ gingival trauma/recession and tooth wear
• Pregnancy or breastfeeding
• History of allergy or hypersensitivity to any material used in the study
• Cognitive, psychiatric, or physical conditions that may impair compliance with study procedures

Sponsors & Collaborators

• International Islamic University Malaysia: collaborator
• Hasanuddin University: collaborator
• National University of Malaysia: lead
• Universiti Sains Islam Malaysia: collaborator
• Universiti Teknologi MARA (UiTM) Sungai Buloh Campus, Malaysia: collaborator

Study Sites (4)

Faculty of Dentistry, Universiti Kebangsaan Malaysia

Kuala Lumpur, Kuala Lumpur, 50300, Malaysia

Location

Faculty of Dentistry, Universiti Sains Islam Malaysia

Kuala Lumpur, Kuala Lumpur, 55100, Malaysia

Location

Kulliyyah of Dentistry, International Islamic University Malaysia

Kuantan, Pahang, 25200, Malaysia

Location

Faculty of Dentistry, Universiti Teknologi MARA

Sungai Buloh, Selangor, 47000, Malaysia

Location

MeSH Terms

Conditions

Gingivitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Amanah Pertiwisari, drg, M.KG

CONTACT

+60 10-5871-889; p154143@siswa.ukm.edu.my

Shahida Mohd Said, BDS, MClinDent (Periodontology

CONTACT

shahidams@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the behavioural intervention, participants, care providers, and investigators cannot be blinded to group allocation. However, outcome assessors responsible for the clinical examinations will remain blinded to treatment allocation. The examiners will not be involved in participant training or intervention delivery, and participants will be instructed not to disclose their allocated intervention during clinical assessments. Statistical analyses will be performed using anonymised datasets with coded treatment groups by an independent data analyst who will remain blinded to treatment allocation until completion of the primary analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Clinical Specialist in Periodontology, Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive the same study procedures, including professional oral prophylaxis, standardised oral hygiene education, structured training delivered through a dedicated mobile application, and identical monitoring throughout the 21-day intervention period. The intervention differs only in the oral hygiene tool and the intervention-specific training provided. Outcomes will be assessed at baseline and Day 21 using standardised clinical assessment procedures.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (4)