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A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou

2026年9月7日 更新者:Jieyun Yin、Soochow University

This study aims to evaluate the effectiveness of a comprehensive oral health intervention program among preschool and primary school children in Suzhou, China.

Preschools and primary schools in selected districts of Suzhou will be assigned to intervention or control groups. Children in the intervention group will receive a comprehensive oral health program involving oral health education, toothbrushing and rinsing instruction and practice, school- and family-based behavioral support, oral health promotion materials, and interactive educational activities. Children in the control group will receive basic oral health education and educational materials.

Oral health examinations, anthropometric assessments, questionnaires, and other follow-up assessments will be conducted to evaluate changes in dental caries, oral hygiene, gingival health, oral health-related knowledge, and oral health behaviors. Participants will be followed for up to three years after the baseline assessment.

研究概览

详细说明

Dental caries is an important oral health problem among children. This study is designed to establish and evaluate an integrated oral health management model involving children, families, schools, and healthcare institutions.

The study will be conducted in selected districts of Suzhou, China, and will include children attending participating preschools and primary schools. Preschool children in the first year of kindergarten and first-grade primary school students will be invited to participate.

Participating schools will be allocated to an intervention group or a control group. The intervention group will receive a comprehensive oral health intervention consisting of oral health education, toothbrushing and rinsing instruction and practice, audiovisual educational materials, school-based oral health promotion, family involvement, behavioral reinforcement, and interactive or gamified oral health activities. The control group will receive basic oral health education and educational materials.

At baseline and during follow-up, oral health examinations will be conducted to assess dental caries and other oral health indicators. Additional assessments may include plaque status, gingival health, anthropometric measurements, questionnaires regarding oral health knowledge and behaviors, and collection of oral microbial samples.

Participants will be followed longitudinally for three years to evaluate the effectiveness of the comprehensive intervention in improving children's oral health and oral health-related behaviors.

研究类型

介入性

注册 (估计的)

2040

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Jieyun Yin, Ph.D.
  • 电话号码:+86 0512 6588036
  • 邮箱:jyyin@suda.edu.cn

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Children in participating preschools or primary schools in selected districts of Suzhou, China.
  • Children in the first year of preschool or the first grade of primary school at baseline.
  • Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

  • Children with severe systemic diseases were excluded.
  • Children who could not cooperate with the oral examination were excluded.
  • Children who transferred/moved out during the expected follow-up period were excluded.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
无干预:Basic Oral Health Education
实验性的:Comprehensive Oral Health Intervention

The comprehensive intervention includes:

Oral health education delivered through lectures, classroom activities, videos, and educational materials.

Instruction and practice in appropriate toothbrushing and mouth-rinsing techniques.

Supervision and reinforcement of oral hygiene behaviors by teachers and parents.

Oral health educational materials, including posters, brochures, tooth models, and audiovisual materials.

Interactive and gamified oral health activities. Behavioral reinforcement activities, such as oral hygiene practice and oral health check-in activities.

Family-based oral health education and behavioral support. School-based oral health promotion activities.

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
dmft/DMFT
大体时间:From enrollment to the end of treatment at 3 years

Dental caries: DMFT/dmft index D/d: crown with obvious caries, or softening of the bottom wall of the cavity, or filled due to caries (including secondary caries).

M/m: loss due to caries (permanent teeth) or early loss due to caries (primary teeth).

F/f: filling due to caries without secondary caries.

From enrollment to the end of treatment at 3 years

次要结果测量

结果测量
措施说明
大体时间
Gingival Index
大体时间:From enrollment to the end of treatment at 3 years

The color, texture, and bleeding tendency of the gums were observed by probing, and the gingival condition of each tooth was rated as 0-3 points (subjective judgment of the doctor).

Methods: A blunt tip periodontal probe was used, combined with visual examination and probing. The kindergartners selected 4 representative teeth: 51, 61, 75, 85, and the primary students selected 6 representative teeth: 16, 21, 24, 36, 41, 44 (if the representative teeth were not erupted, they were replaced by the adjacent erupted teeth). Each tooth was examined at 4 sites and the average score was recorded.

Scoring criteria:

Score 0: healthy gums with no inflammation and no bleeding on probing. Score 1: mild inflammation (slight change in color and texture) without bleeding on probing.

Score 2: moderate inflammation (redness, edema, light), bleeding on probing. Score 3: severe inflammation (marked redness, hypertrophy, or ulceration) with a tendency to spontaneous bleeding.

From enrollment to the end of treatment at 3 years
Plaque Index
大体时间:From enrollment to the end of treatment at 3 years

he dentist applied plaque stain (2% basic fuchsin solution or children's specific erythraea red tablet) to the entire tooth surface, waited 30 seconds, rinsed the mouth with water for 30 seconds, then observed the stained plaque attachment area, and scored according to the tooth surface area (kindergartners examined 4 index teeth: 51, 61, 75, 85, primary school students examined 6 teeth: 16, 21, 24, 36, 41, 44) (if the representative tooth has not yet erupted, it will be replaced by the adjacent erupted tooth), 0-3 points (subjective judgment of doctors) Methods: Smear the whole tooth surface with plaque display agent, gargle with water, and observe the stained area. Each tooth was examined on four tooth surfaces, and the average score was recorded.

Scoring criteria:

Score 0: no plaque in the gingival margin area. Score 1: The tip of the probe gently scratched the tooth surface, and a small amount of plaque was observed (not visible to the naked eye).

Score 2: moderate amount of

From enrollment to the end of treatment at 3 years
Scale index
大体时间:From enrollment to the end of treatment at 3 years

The scale coverage area of the teeth was evaluated by visual inspection, and the cleaning effect of daily brushing was quickly determined. Six designated tooth surfaces were examined: 16 buccal, 11 labial, 26 buccal, 31 labial, 36 lingual, and 46 lingual. Kindergarten-aged children were simplified to 4 primary teeth (51, 61, 75, 85).

0 point: no soft scale and no exogenous pigmentation on the tooth surface

  1. point: the scale covered less than 1/3 of the tooth surface; Or no soft dirt but the presence of pigment stains
  2. points: the soft scale covered 1/3 to 2/3 of the tooth surface
  3. points: soft scale covering > 2/3 of the tooth surface (a large amount of food debris accumulation) Total score ÷6 = individual mean soft scale index DI-S
From enrollment to the end of treatment at 3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月8日

初级完成 (估计的)

2029年6月30日

研究完成 (估计的)

2029年6月30日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 86560320

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data (IPD) will not be made publicly available. The study involves pediatric participants, and the collected oral health data may include potentially sensitive individual-level clinical and demographic information. Although study data will be de-identified for analysis, sharing individual-level data outside the study team may still pose a potential risk of re-identification, particularly given the involvement of minors. In addition, external sharing of individual participant data is not covered by the current informed consent and/or ethics approval. Therefore, only aggregated study results will be reported or published, and no individual participant dataset will be publicly shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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