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Completed

NCT Number: NCT07579403

Fluoride vs Probiotic Toothpaste for Caries Prevention

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

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Key information

Conditions

Dental Caries Behavior Child Behavior Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

48 month–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride Toothpaste

Drug

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

Other names: comeno fluoride toothpaste

Probiotic Toothpaste

Biological

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

Other names: Yunnan Baiyao Children's Toothpaste, Lactobacillus paracasei

Control toothpaste

Other

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

Other names: Beilele Children's Toothpaste

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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