Fluoride vs Probiotic Toothpaste for Caries Prevention

NCT07579403 | Completed Phase 4

• 1 other identifier: QYFYWZLL29924
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of newly severe decayed surfaces

  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

  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

  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

Study Arms (3)

950 ppm Fluoride Toothpaste

EXPERIMENTAL

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

Probiotic Toothpaste

EXPERIMENTAL

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

Control Toothpaste

ACTIVE COMPARATOR

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

Interventions

Probiotic Toothpaste BIOLOGICAL

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

Also known as: Yunnan Baiyao Children's Toothpaste, Lactobacillus paracasei

Probiotic Toothpaste

Control Toothpaste OTHER

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

Also known as: Beilele Children's Toothpaste

Control Toothpaste

Fluoride toothpaste DRUG

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

Also known as: comeno fluoride toothpaste

950 ppm Fluoride Toothpaste

Eligibility Criteria

• Age: 48 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Children whose parents or guardians did not provide informed consent
• Presence of systemic diseases or mental health disorders
• Long-term medication use

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Conditions

Dental Caries; Child Behavior

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (1)