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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Shandong
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Qingdao, Shandong, 중국, 266003
- The Affiliated Hospital of Qingdao University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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실험적: 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.
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Contains Lactobacillus paracasei.
Used for tooth brushing three times daily.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of newly severe decayed surfaces
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Fluoride toothpaste에 대한 임상 시험
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