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)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amanah Pertiwisari, drg, M.KG
- Número de teléfono: +60 10-5871-889
- Correo electrónico: p154143@siswa.ukm.edu.my
Copia de seguridad de contactos de estudio
- Nombre: Shahida Mohd Said, BDS, MClinDent (Periodontology
- Correo electrónico: shahidams@ukm.edu.my
Ubicaciones de estudio
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 50300
- Faculty of Dentistry, Universiti Kebangsaan Malaysia
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Contacto:
- Nik Madihah Nik Azis, Dclindent Periodontology
- Número de teléfono: 0133410210
- Correo electrónico: nikmadihah@ukm.edu.my
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Kuala Lumpur, Kuala Lumpur, Malasia, 55100
- Faculty of Dentistry, Universiti Sains Islam Malaysia
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Contacto:
- Número de teléfono: 0133410210
- Correo electrónico: nikmadihah@ukm.edu.my
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Pahang
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Kuantan, Pahang, Malasia, 25200
- Kulliyyah of Dentistry, International Islamic University Malaysia
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Selangor
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Sungai Buloh, Selangor, Malasia, 47000
- Faculty of Dentistry, Universiti Teknologi MARA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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. |
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Plaque Index (PI)
Periodo de tiempo: Baseline (day 0) and day 21 after randomisation
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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.
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Baseline (day 0) and day 21 after randomisation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Gingival Index (GI)
Periodo de tiempo: Baseline (day 0) and day 21 after randomisation
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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.
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Baseline (day 0) and day 21 after randomisation
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Organización de la neumonía
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades del sistema inmunológico
- Infecciones
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Enfermedades gingivales
- Bronquiolitis Obliterante
- Bronquiolitis
- Bronquitis
- Enfermedad de injerto contra huésped
- Síndrome de bronquiolitis obliterante
- Gingivitis
Otros números de identificación del estudio
- DD-2026-013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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