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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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. Compl

Первичные конечные точки

• Change in Plaque Index (PI) [Срок оценки: Baseline (day 0) and day 21 after randomisation]

Вторичные конечные точки (1)

• Change in Gingival Index (GI) [Срок оценки: Baseline (day 0) and day 21 after randomisation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Малайзия · 4 центра

• Faculty of Dentistry, Universiti Kebangsaan Malaysia — Kuala Lumpur
• Faculty of Dentistry, Universiti Sains Islam Malaysia — Kuala Lumpur
• Kulliyyah of Dentistry, International Islamic University Malaysia — Kuantan
• Faculty of Dentistry, Universiti Teknologi MARA — Sungai Buloh

Идентификаторы

NCT: NCT07702383 · DD-2026-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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