ChildrenNCT07808203
A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou
A study testing Comprehensive Oral Health Intervention in people with Children and Dental Caries, run by Soochow University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Dental Caries
- What is being tested?
- Comprehensive Oral Health Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Children, Dental Caries
- Being tested
- Comprehensive Oral Health Intervention
- Keywords
- children, dental caries, children-family-school-healthcare
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Oral Health InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Basic Oral Health Education | No intervention | Not described |
| Comprehensive Oral Health Intervention | Experimental | Not described Receives: Behavioral: Comprehensive Oral Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 3 years
Secondary outcomes (3)
Gingival Index
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.
Measured: From enrollment to the end of treatment at 3 years
Plaque Index
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
Measured: From enrollment to the end of treatment at 3 years
Scale index
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
Measured: From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Jieyun Yin, Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808203
- Sponsor's protocol ID
- 86560320
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 41275321Ghasemi 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.
PubMed 39317588Atif 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.
PubMed 37840214Bramantoro 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.
PubMed 34379685Stein 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.
PubMed 28815661WHO. Oral Health Surveys: Basic Methods. 5th ed. Geneva: World Health Organization; 2013.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou
- ClinicalTrials.gov ID
- NCT07808203
- Acronym / sponsor ID
- 86560320
- Conditions
- Children, Dental Caries
- Keywords
- children, dental caries, children-family-school-healthcare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- Soochow UniversityUniversity, hospital or other
- Collaborators
- Suzhou Center for Disease Control and Prevention
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Oral Health Education | No intervention | – |
| Comprehensive Oral Health Intervention | Experimental | Behavioral: Comprehensive Oral Health Intervention |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Oral Health InterventionThe 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. | Behavioural | Comprehensive Oral Health Intervention |
Primary outcome
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.
3 secondary outcomes
Gingival Index
Time frame: From enrollment to the end of treatment at 3 years
Plaque Index
Time frame: From enrollment to the end of treatment at 3 years
Scale index
Time frame: From enrollment to the end of treatment at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 41275321Tavakoli 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.
- Background: PubMed 39317588Ghasemi 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.
- Background: PubMed 37840214Atif 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.
- Background: PubMed 34379685Bramantoro 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.
- Background: PubMed 28815661Stein 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.
- BackgroundWHO. Oral Health Surveys: Basic Methods. 5th ed. Geneva: World Health Organization; 2013.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Oral Health Intervention in people with Children and Dental Caries, run by Soochow University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Hu, Ph.D. (+86-512-62701715, hujia200606@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dmft/DMFT (time frame: From enrollment to the end of treatment at 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808203, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.