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Fluoride vs Probiotic Toothpaste for Caries Prevention

NCT07579403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2026-05-12

No results posted yet for this study

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

Conditions

  • Dental Caries
  • Child Behavior

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579403 on ClinicalTrials.gov