Effectiveness of Single and Dual Silver Fluoride Application
The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial
This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years.
The main questions this study aims to answer are:
i) Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire?
Researchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes.
Participants will:
i) Undergo oral examination for assessment of dentinal caries using ICDAS criteria.
ii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months.
iii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status.
iv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD
- Número de teléfono: +6010-2716747
- Correo electrónico: azlida@um.edu.my
Copia de seguridad de contactos de estudio
- Nombre: Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent
- Número de teléfono: +6012-5250520
- Correo electrónico: tengkunurfarhana@um.edu.my
Ubicaciones de estudio
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Perak
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Tapah, Perak, Malasia, 35000
- Preschools in Perak
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Contacto:
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
- Número de teléfono: 016-7786161
- Correo electrónico: dr.mohamadnoor@moh.gov.my
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Investigador principal:
- Nurfazlina Rosman (Dr), DDS, MCOH
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Sub-Investigador:
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 4-6 years enrolled in selected preschools.
- Presence of at least one active dentinal caries lesion.
- Parental or guardian consent obtained.
- Asymptomatic cavitated dentine carious lesions in primary teeth.
- Parents/caregivers who understand the Malay language.
Exclusion Criteria:
- Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula.
- Systemic illness or medical contraindications for SF use.
- Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.
- History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).
- Children who have received professionally applied fluoride within the past six months at the time of recruitment.
- Arrested caries lesion.
- Children presenting with oral ulceration or mucositis.
- Uncooperative behaviour precluding oral examination.
- Children with pre-shedding tooth mobility
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Single Application of Silver Fluoride
Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months
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Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up.
One drop (0.05 mL) treats up to five surfaces.
Maximum dose per visit does not exceed 260 µL.
Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
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Experimental: Dual Application of Silver Fluoride
Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.
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Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up.
One drop (0.05 mL) treats up to five surfaces.
Maximum dose per visit does not exceed 260 µL.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caries arrest at tooth surface level
Periodo de tiempo: 6 months
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Lesions are considered arrested if they are hard upon probing using WHO probe and have turned black in colour.
Each tooth may contribute up to five surfaces, with analysis conducted at the lesion level.
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6 months
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Proportion of arrested lesions
Periodo de tiempo: 6 months
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Caries arrest will be assessed at the tooth surface level.
The outcome is defined as the proportion of lesions classified as arrested out of the total treated lesions in each group.
Comparisons will be made between single and dual application groups.
Analyses will be conducted at both surface (lesion) level and participant level, accounting for clustering of lesions within individuals.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in OHRQoL (Malay-ECOHIS score)
Periodo de tiempo: Baseline to 6 months
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Change in total Malay-ECOHIS score from baseline to 6 months will be assessed.
The Malay-ECOHIS is a validated parent-reported questionnaire measuring the impact of oral health on children and their families.
Scores range from 0 to 52, with higher scores indicating worse oral health-related quality of life.
A reduction in score reflects improvement in OHRQoL.
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Baseline to 6 months
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To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
Periodo de tiempo: 0-6 months
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This outcome will assess the correlation between caries arrest rate at 6 months and change in total Malay-ECOHIS score from baseline to 6 months. Caries arrest rate (%) will be assessed by clinical examination and calculated as the number of arrested treated dentinal caries lesions divided by the total number of treated dentinal caries lesions per participant, multiplied by 100. The unit of measure is percentage (%) of arrested treated dentinal caries lesions. Change in total Malay-ECOHIS score will be assessed using the Malay-ECOHIS questionnaire. The change score will be calculated as the total score at 6 months minus the baseline total score. The unit of measure is change in total Malay-ECOHIS score. Pearson correlation will be used if normality assumptions are met; otherwise, Spearman rank correlation will be used. |
0-6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD, Universiti Malaya
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- DF CO2505/0018 (P)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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