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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Shandong
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Qingdao、Shandong、中国、266003
- The Affiliated Hospital of Qingdao University
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
其他名称：
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实验性的：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.
其他名称：
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有源比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of newly severe decayed surfaces
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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