Orthodontic Treatment on Oral Microbiota and Salivary Proteins
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorXi'an Jiaotong University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No carries and White spot
No missing teeth
No history of oral treatment
No malocclusion
Disqualifiers
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
Trial population
A description of the population from the population undergoing oral health examinations in primary schools
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no interventions
Other interventionno intervention as this is an observational studies
None-placebo
Other interventionObservational study with no interventions
No Intervention: Observational Cohort
Other interventionno intervention because of observational studies
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: ID number3 interventions
Trial outcomes
Primary outcomes
1
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.2
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.3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov