Orthodontic Treatment on Oral Microbiota and Salivary Proteins

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

no intervention as this is an observational studies

None-placebo

Other

Observational study with no interventions

No Intervention: Observational Cohort

Other

no intervention because of observational studies

Primary outcomes

Microbiota changes of plaque

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.

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 saliva

Time frame: Baseline, 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 progression

Time frame: Baseline, 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shan shan Dai

CONTACT

[email protected]

86+15319976663

Sponsors and collaborators

Lead sponsor

Xi'an Jiaotong University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Feb 13, 2025
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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