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

7 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

2040

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Basic Oral Health Education
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
dmft/DMFT
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gingival Index
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

8 oktober 2026

Primaire voltooiing (Geschat)

30 juni 2029

Studie voltooiing (Geschat)

30 juni 2029

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2026

Eerst geplaatst (Werkelijk)

8 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

7 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 86560320

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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