An interventional study of Comprehensive Oral Health Intervention in Children and Dental Caries, sponsored by Soochow University. Not yet recruiting. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Soochow University · Not applicable, Interventional, and Prevention
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.
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.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 2,040 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Soochow University is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: 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.
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.
Time frame: From enrollment to the end of treatment at 3 years
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.
Time frame: 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
Time frame: 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 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
Time frame: From enrollment to the end of treatment at 3 years
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Jun 2029, 32 months later.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 32 months is above that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Soochow University