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NCT Number: NCT07808203

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

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.

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Key information

Conditions

Children Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Oral Health Intervention

Behavioral

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.

Primary outcomes

  1. dmft/DMFT

    Time frame: 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.

Secondary outcomes

  1. Gingival Index

    Time frame: 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.

  2. Plaque Index

    Time frame: 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

  3. Scale index

    Time frame: 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

    • point: the scale covered less than 1/3 of the tooth surface; Or no soft dirt but the presence of pigment stains
    • points: the soft scale covered 1/3 to 2/3 of the tooth surface
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Hu, Ph.D.

CONTACT

[email protected]

+86-512-62701715

Jieyun Yin, Ph.D.

CONTACT

[email protected]

+86 0512 6588036

Sponsors and collaborators

Lead sponsor

Soochow University

Other

Collaborators

  • Suzhou Center for Disease Control and Prevention

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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