Dentine Caries
Conditions
Keywords
Silver Fluoride, Caries Arrest, Randomised Controlled Trial, Preschool Children, Silver Diamine Fluoride
Brief summary
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.
Interventions
DRUG38% Silver Fluoride (Riva Star Aqua)
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.
OTHERNormal Saline (Placebo)
Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a double-blinded study. Participants and outcome assessors will be blinded to group allocation. A placebo, normal saline in a foil-wrapped bottle, will be used at the 3-month visit in the single-application group to maintain blinding
Intervention model description
This study is a parallel-group, double-blinded randomised controlled trial. Participants will be allocated in a 1:1 ratio to either single or dual application of 38% silver fluoride and will remain in their assigned group throughout the study period. Outcomes will be compared between groups at follow-up. Randomisation will be performed at the individual child level.
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 4-6 years enrolled in selected preschools. 2. Presence of at least one active dentinal caries lesion. 3. Parental or guardian consent obtained. 4. Asymptomatic cavitated dentine carious lesions in primary teeth. 5. Parents/caregivers who understand the Malay language.
Exclusion criteria
1. Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula. 2. Systemic illness or medical contraindications for SF use. 3. Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta. 4. History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF). 5. Children who have received professionally applied fluoride within the past three months at the time of recruitment. 6. Arrested caries lesion. 7. Children presenting with oral ulceration or mucositis. 8. Uncooperative behaviour precluding oral examination. 9. Children with pre-shedding tooth mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries arrest at tooth surface level | 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. |
| Proportion of arrested lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in OHRQoL (Malay-ECOHIS score) | 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. |
| To determine correlation between caries arrest rate and change in total Malay-ECOHIS score | 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. |
Countries
Malaysia
Contacts
CONTACTNor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD
CONTACTDr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent
PRINCIPAL_INVESTIGATORNor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD
University of Malaya
Outcome results
None listed