drugset / Trial / NCT07579403

Fluoride vs Probiotic Toothpaste for Caries Prevention

NCT07579403

Phase 4 Completed 508 enrolled The Affiliated Hospital of Qingdao University
RandomizedParallel-groupSingle-blindPrevention

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

Timeline

Start
2023-01-01
Primary completion
2024-06-01
Completion
2024-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoride Other / unclassified 950 ppm
Subject Lactobacillus paracasei Unknown

Indications