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Orthodontic Treatment on Oral Microbiota and Salivary Proteins

Orthodontic Treatment on Oral Microbiota and Salivary Proteins

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06824493
Enrollment
150
Registered
2025-02-13
Start date
2025-07-01
Completion date
2027-09-01
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontics, White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, Caries, Dental

Keywords

microbiota

Brief summary

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.

Interventions

OTHERno interventions

no intervention as this is an observational studies

Observational study with no interventions

OTHERNo Intervention: Observational Cohort

no intervention because of observational studies

Sponsors

Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* No carries and White spot * No missing teeth * No history of oral treatment * No malocclusion * No systemic diseases

Exclusion criteria

* Antibiotic use in the past three months * A history of long-term medication use * A history of dental fillings * Unable to attend regular follow-ups

Design outcomes

Primary

MeasureTime frameDescription
Microbiota changes of plaquebaseline, 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.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
Microbiota changes of salivaBaseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.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
Monitoring dental lesion progressionBaseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.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

Contacts

Primary ContactShan shan Dai
daishanshan0723@163.com86+15319976663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026