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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dentine Caries
• Intervention / Treatment: Drug: 38% Silver Fluoride (Riva Star Aqua); Other: Normal saline (palcebo)

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD; Phone Number: +6010-2716747; Email: azlida@um.edu.my
• Study Contact Backup: Name: Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent; Phone Number: +6012-5250520; Email: tengkunurfarhana@um.edu.my

Study Locations

• Malaysia
  • Perak
    • Tapah, Perak, Malaysia, 35000
      • Preschools in Perak
      • Contact: Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate; Phone Number: 016-7786161; Email: dr.mohamadnoor@moh.gov.my
      • Principal Investigator: Nurfazlina Rosman (Dr), DDS, MCOH
      • Sub-Investigator: Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 six 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: 38% 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.; Other: Normal saline (palcebo); Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
Experimental: Dual Application of Silver Fluoride; Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.	Drug: 38% 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0-6 months

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD, Universiti Malaya

Publications and helpful links

General Publications

• Yan IG, Zheng FM, Gao SS, Duangthip D, Lo ECM, Chu CH. A Review of the Protocol of SDF Therapy for Arresting Caries. Int Dent J. 2022 Oct;72(5):579-588. doi: 10.1016/j.identj.2022.06.006. Epub 2022 Jul 14.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Silver Diamine Fluoride; Randomised Controlled Trial; Preschool Children; Silver Fluoride; Caries Arrest
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution; silver fluoride
• Other Study ID Numbers: DF CO2505/0018 (P)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No