Dental CariesPhase 4NCT07579403
Fluoride vs Probiotic Toothpaste for Caries Prevention
A Phase 4 study testing Fluoride toothpaste and Probiotic Toothpaste in people with Dental Caries and Child Behavior, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Child Behavior
- What is being tested?
- Fluoride toothpaste and Probiotic Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official 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
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:
Read more
- 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
Read the 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.
- Conditions
- Dental Caries, Child Behavior
- Being tested
- Fluoride toothpaste, Probiotic Toothpaste, Control Toothpaste
- Medical subject headings
- Dental Caries, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride toothpasteDrug
Also called comeno fluoride toothpaste
Contains 950 ppm fluoride. Used for tooth brushing three times daily.
Probiotic ToothpasteBiological
Also called Yunnan Baiyao Children's Toothpaste, Lactobacillus paracasei
Contains Lactobacillus paracasei. Used for tooth brushing three times daily.
Control ToothpasteOther
Also called Beilele Children's Toothpaste
Toothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jan 2023
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579403
- Sponsor's protocol ID
- QYFYWZLL29924
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07579403
- Acronym / sponsor ID
- QYFYWZLL29924
- Conditions
- Dental Caries, Child Behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 950 ppm Fluoride Toothpaste | Experimental | Drug: Fluoride toothpasteChildren 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. |
| Probiotic Toothpaste | Experimental | Biological: Probiotic ToothpasteChildren 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. |
| Control Toothpaste | Active comparator | Other: Control ToothpasteChildren 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. |
Who may qualify
- Ages
- 48 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride toothpasteAlso: comeno fluoride toothpasteContains 950 ppm fluoride. Used for tooth brushing three times daily. | Drug | 950 ppm Fluoride Toothpaste |
| Probiotic ToothpasteAlso: Yunnan Baiyao Children's Toothpaste, Lactobacillus paracaseiContains Lactobacillus paracasei. Used for tooth brushing three times daily. | Biological | Probiotic Toothpaste |
| Control ToothpasteAlso: Beilele Children's ToothpasteToothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily. | Other | Control Toothpaste |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoride toothpaste and Probiotic Toothpaste in people with Dental Caries and Child Behavior, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of newly severe decayed surfaces (time frame: Baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.