A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou
1 other identifier
interventional
2,040
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 8, 2026
CompletedStudy Start
First participant enrolled
October 8, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
Study Completion
Last participant's last visit for all outcomes
June 30, 2029
September 10, 2026
August 1, 2026
2.7 years
August 18, 2026
September 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
dmft/DMFT
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
Secondary Outcomes (3)
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
Study Arms (2)
Basic Oral Health Education
NO INTERVENTIONComprehensive Oral Health Intervention
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Tavakoli S, Saadatfar N, Tiyuri A. The effectiveness of school-based supervised tooth brushing intervention for preventing dental caries: a systematic review and meta-analysis. BMC Oral Health. 2025 Nov 22;25(1):1967. doi: 10.1186/s12903-025-07299-y.
PMID: 41275321BACKGROUNDGhasemi H, Alautry HF, Khoshnevisan MH, Namdari M. Effectiveness of a School-Based Oral Health Promotion Program on Dental Caries Among Iraqi School Children: A Cluster Randomised Controlled Trial. Int Dent J. 2025 Apr;75(2):744-751. doi: 10.1016/j.identj.2024.07.1214. Epub 2024 Sep 24.
PMID: 39317588BACKGROUNDAtif M, Tewari N, Saji S, Srivastav S, Rahul M. Effectiveness of various methods of educating children and adolescents for the maintenance of oral health: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2024 May;34(3):229-245. doi: 10.1111/ipd.13125. Epub 2023 Oct 15.
PMID: 37840214BACKGROUNDBramantoro T, Santoso CMA, Hariyani N, Setyowati D, Zulfiana AA, Nor NAM, Nagy A, Pratamawari DNP, Irmalia WR. Effectiveness of the school-based oral health promotion programmes from preschool to high school: A systematic review. PLoS One. 2021 Aug 11;16(8):e0256007. doi: 10.1371/journal.pone.0256007. eCollection 2021.
PMID: 34379685BACKGROUNDStein C, Santos NML, Hilgert JB, Hugo FN. Effectiveness of oral health education on oral hygiene and dental caries in schoolchildren: Systematic review and meta-analysis. Community Dent Oral Epidemiol. 2018 Feb;46(1):30-37. doi: 10.1111/cdoe.12325. Epub 2017 Aug 16.
PMID: 28815661BACKGROUNDWHO. Oral Health Surveys: Basic Methods. 5th ed. Geneva: World Health Organization; 2013.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
August 18, 2026
First Posted
September 8, 2026
Study Start (Estimated)
October 8, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
September 10, 2026
Record last verified: 2026-08