Clinical Trial

Fluoride vs Probiotic Toothpaste for Caries Prevention

Completed Phase 4
View on ClinicalTrials.gov →
Summary
This clinical trial had two objectives. The first was to compare the effectiveness of 950 ppm fluoride toothpaste versus probiotic toothpaste in preventing dental caries in 4- to 5-year-old children. The second was to understand how children's oral hygiene habits and dietary habits influence the development of dental caries. The main questions it aimed to answer are: * Does fluoride toothpaste reduce new caries more than control toothpaste? * Does probiotic toothpaste reduce new caries more than control toothpaste? * Which oral hygiene and dietary habits are risk factors for dental caries? Researchers compared fluoride toothpaste and probiotic toothpaste to a control toothpaste (without active ingredients). Participants were asked to complete the following tasks: * Complete a questionnaire about their oral hygiene and dietary habits at baseline * Undergo oral health examinations at baseline and after 12 months * Brush their teeth twice daily (morning and before bedtime) with their assigned toothpaste for 12 months * Use a pea-sized amount of toothpaste each time * Brush under the supervision of parents to ensure brushing quality
Trial Details
NCT Number NCT07579403
Lead Sponsor The Affiliated Hospital of Qingdao University
Conditions Dental Caries, Child Behavior
Enrollment 508 participants
Start Date 2023-01-01
Primary Completion 2024-06-01 (estimated)
Study Completion 2024-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12