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COMPLETED
NCT07579403
PHASE4

Fluoride vs Probiotic Toothpaste for Caries Prevention

Sponsor: The Affiliated Hospital of Qingdao University

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

Official title: Study on Influencing Factors of Dental Caries in 4- to 5-Year-Old Children in Pingdu City and the Effectiveness of Different Toothpastes in Preventing Childhood Caries

Key Details

Gender

All

Age Range

48 Months - 59 Years

Study Type

INTERVENTIONAL

Enrollment

508

Start Date

2023-01-01

Completion Date

2024-09-01

Last Updated

2026-05-12

Healthy Volunteers

Yes

Interventions

DRUG

Fluoride toothpaste

Contains 950 ppm fluoride. Used for tooth brushing three times daily.

BIOLOGICAL

Probiotic Toothpaste

Contains Lactobacillus paracasei. Used for tooth brushing three times daily.

OTHER

Control Toothpaste

Toothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China