A Phase 4 interventional study of Fluoride toothpaste and Probiotic Toothpaste in Dental Caries and Child Behavior, sponsored by The Affiliated Hospital of Qingdao University. Completed at 1 site in China. Open to participants aged 48 Months to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by The Affiliated Hospital of Qingdao University · Phase 4, Interventional, and 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:
Researchers compared fluoride toothpaste and probiotic toothpaste to a control toothpaste (without active ingredients).
Participants were asked to complete the following tasks:
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):
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 508 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Contains 950 ppm fluoride. Used for tooth brushing three times daily.
Also known as: comeno fluoride toothpaste
Contains Lactobacillus paracasei. Used for tooth brushing three times daily.
Also known as: Yunnan Baiyao Children's Toothpaste, Lactobacillus paracasei
Toothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily.
Also known as: Beilele Children's Toothpaste
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lacticaseibacillus paracasei
The Affiliated Hospital of Qingdao University →