Effectiveness of Single and Dual Silver Fluoride Application
ConditionDentine Caries
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-6
SponsorUniversity of Malaya
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- 38% Silver Fluoride (Riva Star Aqua)
- Normal saline (palcebo)
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov