Orthodontic Treatment on Oral Microbiota and Salivary Proteins

NCT06824493 | Not Yet Recruiting

• 1 other identifier: XJKQLY202503
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

microbiota

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.

Study Arms (1)

ID number

Other: no interventions; Other: None-placebo; Other: No Intervention: Observational Cohort

Interventions

no interventions OTHER

no intervention as this is an observational studies

ID number

None-placebo OTHER

Observational study with no interventions

ID number

No Intervention: Observational Cohort OTHER

no intervention because of observational studies

ID number

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A description of the population from the population undergoing oral health examinations in primary schools

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Shan shan Dai

CONTACT

86+15319976663; daishanshan0723@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician of pediatric dentist and PhD in Orthodontics

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: February 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05