A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,040
- 主要终点
- dmft/DMFT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Basic Oral Health Education
Comprehensive Oral Health Intervention
干预措施: Comprehensive Oral Health Intervention (Behavioral)
结局指标
主要结局
dmft/DMFT
时间窗: 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.
次要结局
- Gingival Index(From enrollment to the end of treatment at 3 years)
- Plaque Index(From enrollment to the end of treatment at 3 years)
- Scale index(From enrollment to the end of treatment at 3 years)
研究者
Jieyun Yin
associate professor
Soochow University