Effectiveness of Single and Dual Silver Fluoride Application

NCT07658690 | Not Yet Recruiting Phase 3

• 1 other identifier: DF CO2505/0018 (P)
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Caries

Keywords

Silver Fluoride; Caries Arrest; Randomised Controlled Trial; Preschool Children; Silver Diamine Fluoride

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in OHRQoL (Malay-ECOHIS score)

  Baseline to 6 months

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

  0-6 months

Study Arms (2)

Single Application of Silver Fluoride

PLACEBO COMPARATOR

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); Other: Normal Saline (Placebo)

Dual Application of Silver Fluoride

EXPERIMENTAL

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)

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.

Dual Application of Silver Fluoride; Single Application of Silver Fluoride

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

Single Application of Silver Fluoride

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Preschools in Perak

Tapah, Perak, 35000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 35843730 BACKGROUND

MeSH Terms

Interventions

silver fluoride; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD

CONTACT

+6010-2716747; azlida@um.edu.my

Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent

CONTACT

+6012-5250520; tengkunurfarhana@um.edu.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)