Effectiveness of Single and Dual Silver Fluoride Application

Phase 3Not Yet RecruitingNCT07658690

University of Malaya148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

148

Conditions

Dentine Caries

Interventions

38% Silver Fluoride (Riva Star Aqua)DRUG

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.

Normal Saline (Placebo)OTHER

Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Caries arrest at tooth surface level

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.

Time frame: 6 months

Proportion of arrested lesions

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.

Time frame: 6 months

Secondary Outcomes

Change in OHRQoL (Malay-ECOHIS score)

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.

Time frame: Baseline to 6 months

To determine correlation between caries arrest rate and change in total Malay-ECOHIS score

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.

Time frame: 0-6 months