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Fluoride vs Probiotic Toothpaste for Caries Prevention

7. maj 2026 opdateret af: The Affiliated Hospital of Qingdao University

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

508

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shandong
      • Qingdao, Shandong, Kina, 266003
        • The Affiliated Hospital of Qingdao University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Fluoride toothpaste
Contains 950 ppm fluoride. Used for tooth brushing three times daily.
Andre navne:
  • comeno fluoride toothpaste
Eksperimentel: 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.
Biologisk: Probiotic Toothpaste
Contains Lactobacillus paracasei. Used for tooth brushing three times daily.
Andre navne:
  • Lactobacillus paracasei
  • Yunnan Baiyao Children's Toothpaste
Aktiv komparator: 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.
Andet: Control Toothpaste
Toothpaste without active fluoride or probiotic ingredients. Used for tooth brushing three times daily.
Andre navne:
  • Beilele Children's Toothpaste

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of newly severe decayed surfaces
Tidsramme: 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.
Baseline to 12 months
Number of newly decayed surfaces
Tidsramme: 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.
Baseline to 12 months
Number of newly cavitated surfaces
Tidsramme: 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.
Baseline to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Affiliated Hospital of Qingdao University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2023

Primær færdiggørelse (Faktiske)

1. juni 2024

Studieafslutning (Faktiske)

1. september 2024

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • QYFYWZLL29924

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