Fluoride vs Probiotic Toothpaste for Caries Prevention

May 7, 2026 updated by: The Affiliated Hospital of Qingdao University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design and setting This was a cross-sectional survey combined with a prospective, randomized, single-blind, controlled trial conducted in Pingdu City, China. Five kindergartens (two urban, three rural) were randomly selected.

Cross-sectional survey phase A total of 540 children aged 4-5 years underwent oral examinations performed by two trained and calibrated dentists. Parents completed a questionnaire on children's oral hygiene behaviors and dietary habits.

Randomized controlled trial phase

After baseline assessment, 508 children were randomly assigned to three groups (1:1:1):

  • Fluoride toothpaste group: 950 ppm fluoride toothpaste
  • Probiotic toothpaste group: Toothpaste containing Lactobacillus paracasei
  • Control group: Toothpaste without active ingredients

Participants brushed twice daily (morning and before bedtime) with a pea-sized amount of assigned toothpaste for 12 months under parental supervision. Kindergarten teachers supervised lunchtime brushing. All participants received standardized oral health education at baseline and each semester.

Compliance monitoring Compliance was assessed using daily toothbrushing record cards and collected toothpaste tubes. Only children with moderate or good compliance were included in final analysis.

Ethical approval The study was approved by the Human Research Ethics Committee of The Affiliated Hospital of Qingdao University (Approval No.: QYFYWZLL29924). Written informed consent was obtained from parents or legal guardians, and verbal assent from each child.

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital Of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 4-5 years (48-59 months)
  • Informed consent obtained from parents or guardians, with permanent residence in Pingdu City and willingness to actively cooperate throughout the study
  • No long-term medication use
  • Absence of systemic diseases and mental health disorders

Exclusion Criteria:

  • Not meeting any of the inclusion criteria
  • Children whose parents or guardians did not provide informed consent
  • Presence of systemic diseases or mental health disorders
  • Long-term medication use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 950 ppm Fluoride Toothpaste
Children brushed their teeth three times daily (after breakfast, after lunch, and before bedtime) using 950 ppm fluoride toothpaste (comeno Fluoride Toothpaste, 3M, USA). A pea-sized amount (approximately 0.5 g) was used each time. The intervention lasted 12 months.
Drug: Fluoride toothpaste
Contains 950 ppm fluoride. Used for tooth brushing three times daily.
Other Names:
  • comeno fluoride toothpaste
Experimental: Probiotic Toothpaste
Children brushed their teeth three times daily (after breakfast, after lunch, and before bedtime) using probiotic toothpaste containing Lactobacillus paracasei (Yunnan Baiyao Children's Toothpaste, Yunnan Baiyao, China). A pea-sized amount (approximately 0.5 g) was used each time. The intervention lasted 12 months.
Biological: Probiotic Toothpaste
Contains Lactobacillus paracasei. Used for tooth brushing three times daily.
Other Names:
  • Lactobacillus paracasei
  • Yunnan Baiyao Children's Toothpaste
Active Comparator: Control Toothpaste
Children brushed their teeth three times daily (after breakfast, after lunch, and before bedtime) using control toothpaste without active ingredients (Beilele Children's Toothpaste, Lengsuanling, China). A pea-sized amount (approximately 0.5 g) was used each time. The intervention lasted 12 months.
Other: Control Toothpaste
Toothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily.
Other Names:
  • Beilele Children's Toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of newly severe decayed surfaces
Time Frame: Baseline to 12 months
The change in the number of severe decayed surfaces (ICDAS codes 5-6, indicating caries approaching or exposing the pulp) per child between baseline and 12-month follow-up.
Baseline to 12 months
Number of newly decayed surfaces
Time Frame: Baseline to 12 months
The change in the total number of decayed surfaces (ICDAS codes 1-6, including early enamel lesions) per child between baseline and 12-month follow-up.
Baseline to 12 months
Number of newly cavitated surfaces
Time Frame: Baseline to 12 months
The change in the number of cavitated surfaces (ICDAS codes 3-6, with dentin exposure) per child between baseline and 12-month follow-up.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYFYWZLL29924

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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