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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Shandong
-
Qingdao, Shandong, Kina, 266003
- The Affiliated Hospital of Qingdao University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Contains 950 ppm fluoride.
Used for tooth brushing three times daily.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
|
|
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.
|
Toothpaste without active fluoride or probiotic ingredients.
Used for tooth brushing three times daily.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QYFYWZLL29924
Legemiddel- og utstyrsinformasjon, studiedokumenter
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