Fluoride vs Probiotic Toothpaste for Caries Prevention
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Shandong
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Qingdao, Shandong, China, 266003
- The Affiliated Hospital of Qingdao University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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Contains 950 ppm fluoride.
Used for tooth brushing three times daily.
Andere namen:
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Experimenteel: 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.
|
Contains Lactobacillus paracasei.
Used for tooth brushing three times daily.
Andere namen:
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Actieve vergelijker: 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.
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Toothpaste without active fluoride or probiotic ingredients.
Used for tooth brushing three times daily.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of newly severe decayed surfaces
Tijdsspanne: Baseline to 12 months
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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.
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Baseline to 12 months
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Number of newly decayed surfaces
Tijdsspanne: Baseline to 12 months
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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.
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Baseline to 12 months
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Number of newly cavitated surfaces
Tijdsspanne: Baseline to 12 months
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The change in the number of cavitated surfaces (ICDAS codes 3-6, with dentin exposure) per child between baseline and 12-month follow-up.
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Baseline to 12 months
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- QYFYWZLL29924
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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