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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD
- Numéro de téléphone: +6010-2716747
- E-mail: azlida@um.edu.my
Sauvegarde des contacts de l'étude
- Nom: Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent
- Numéro de téléphone: +6012-5250520
- E-mail: tengkunurfarhana@um.edu.my
Lieux d'étude
-
-
Perak
-
Tapah, Perak, Malaisie, 35000
- Preschools in Perak
-
Contact:
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
- Numéro de téléphone: 016-7786161
- E-mail: dr.mohamadnoor@moh.gov.my
-
Chercheur principal:
- Nurfazlina Rosman (Dr), DDS, MCOH
-
Sous-enquêteur:
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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 three 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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
|
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
|
|
Expérimental: Dual Application of Silver Fluoride
Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Caries arrest at tooth surface level
Délai: 6 months
|
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.
|
6 months
|
|
Proportion of arrested lesions
Délai: 6 months
|
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.
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in OHRQoL (Malay-ECOHIS score)
Délai: Baseline to 6 months
|
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.
|
Baseline to 6 months
|
|
To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
Délai: 0-6 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD, University of Malaya
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DF CO2505/0018 (P)
Plan pour les données individuelles des participants (IPD)
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