An observational study in Orthodontics, White Spot Lesions [Initial Caries] on Smooth Surface of Tooth and Caries, Dental, sponsored by Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Xi'an Jiaotong University · Observational
Study on the changes in oral microbiota during orthodontic treatment in patients aged 8-18 years. Orthodontic patients treated at Stomatology Hospital of Xi'an Jiaotong University from March 2025 to March 2027 will be recruited. Prior to orthodontic treatment, routine preoperative examinations will be conducted, informed consent forms will be signed, baseline oral conditions will be recorded, and oral and psychological-related questionnaires will be completed. Patients will be informed of the need for regular oral hygiene check-ups, caries risk assessments will be performed, and plaque, saliva, and intraoral photographs will be collected. During orthodontic treatment, plaque samples will be collected every 3 months, and saliva samples will be collected every 6 months until the treatment is completed to evaluate the changes in oral microbiota throughout the orthodontic process.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 150 is below the median of 174 across 187 observational studies indexed under Dental Caries.
Browse Dental Caries studies →Xi'an Jiaotong University is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
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A description of the population from the population undergoing oral health examinations in primary schools
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Exclusion Criteria:
Other: no interventions · Other: None-placebo · Other: No Intervention: Observational Cohort
no intervention as this is an observational studies
Observational study with no interventions
no intervention because of observational studies
Microbiota changes of plaque
Samples of supragingival plaques will proceed to 16S rRNA sequencing for analysis of microbiome profiles, and q-PCR for evaluating bacterial loads of some critical pathogens for dental caries
Time frame: baseline, collect plaque in the first month, then at Month 3, 6, 9, 12, 15, 18, 21, 24, 27,30 through study completion, an average of 30 months.
Microbiota changes of saliva
Samples of saliva will proceed to 16S rRNA sequencing for analysis of microbiome profiles, and q-PCR for evaluating bacterial loads of some critical pathogens for dental caries
Time frame: Baseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
Monitoring dental lesion progression
ICDAS(International Caries Detection and Assessment System) scoring system helps in detecting early caries, monitoring lesion progression, and developing tailored treatment strategies. Scoring Criteria: 0: No visible caries; 1: First visual change (only visible when dry); 2: Distinct visual change (visible without drying); 3: Initial enamel breakdown;4: Underlying dark shadow from dentin;5: Moderate cavity with dentin exposure; 6: Extensive cavity with pulp involvement
Time frame: Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
Started Jul 2025 (actual). Primary completion is estimated for Mar 2027, 20 months after the start.
Of 46 non-industry observational studies under Dental Caries, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 20 months is above that.
Counting every sponsor, half of 47 studies reached it within 12 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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Xi'an Jiaotong University