Early childhood caries Dental caries Child, Preschool Sodium fluoride Fluoride varnishes Fluorides, Topical Primary dentition Randomized controlled trial
Conditions
Interventions
2.1% aqueous sodium fluoride solution applied using the unit-dose L-Pop applicator system with an applicator brush to form a thin coating over the tooth surfaces,5% sodium fluoride varnish applied in
Experimental Drug,Active Comparator Drug
Topical aqueous sodium fluoride 2.1 percent,Topical sodium fluoride varnish 5 percent
Sponsors
Faculty of Dentistry, Mahidol University
Eligibility
Sex/Gender
All
Age
3 Years to 4 Years
Inclusion criteria
Inclusion criteria: Subject level 1. Generally healthy children classified as ASA (American Society of Anesthesiologists) Physical Status I 2. Written informed consent obtained from the parents or legal guardians 3. Presence of at least one eligible primary tooth surface with active initial caries at baseline for outcome assessment Tooth surfaces level 1. Active initial caries lesions (ICDAS 2 - 3) eligible for caries progression assessment 2. Sound primary tooth surfaces (ICDAS 0) eligible for caries incidence assessment
Exclusion criteria
Exclusion criteria: Subject level 1. Medical conditions or medications that significantly affect salivary flow or enamel integrity 2. Known history of hypersensitivity or allergic reaction to any component of the fluoride products 3. Inability to complete the baseline oral examination due to persistent uncooperative behavior 4. Parents or primary caregivers who are unable to read and complete the questionnaire Tooth surfaces level 1. Primary tooth surfaces affected by developmental enamel defects including enamel hypoplasia or fluorosis that may interfere with ICDAS scoring 2. Primary teeth with any surface scored as ICDAS 5 - 6 at baseline that requires full-coverage treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of baseline active initial carious lesions on primary tooth surfaces At 6, 12, and 18 months after baseline Visual clinical examination using the International Caries Detection and Assessment System criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of new carious lesions on primary tooth surfaces At 6, 12, and 18 months after baseline Visual clinical examination using the International Caries Detection and Assessment System criteria | — |
Countries
Thailand
Contacts
Public ContactPaksamon Jenvithayavechkul
Department of Pediatric Dentistry, Faculty of Dentistry, Mahidol University
Outcome results
None listed