OrthodonticsNCT06824493
Orthodontic Treatment on Oral Microbiota and Salivary Proteins
An observational study of Orthodontics and White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontics, White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, Caries, Dental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Sep 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A description of the population from the population undergoing oral health examinations in primary schools
Who may be able to join
- No carries and White spot
- No missing teeth
- No history of oral treatment
- No malocclusion
- No systemic diseases
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
tomatology Hospital of Xi'an Jiaotong University,
Xi'an, Shaanxi
Yucheng Guo, 86+15929935365, xjtu-guoyucheng@163.com
About this study
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
- Being tested
- no interventions, None-placebo, No Intervention: Observational Cohort
- Keywords
- microbiota
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no intervention as this is an observational studies
None-placeboOther
Observational study with no interventions
No Intervention: Observational CohortOther
no intervention because of observational studies
| Study group | Role | What they receive |
|---|---|---|
| ID number | Not described Receives: Other: no interventions; Other: None-placebo; Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanshan-Dai, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824493
- Sponsor's protocol ID
- XJKQLY202503
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Treatment on Oral Microbiota and Salivary Proteins
- ClinicalTrials.gov ID
- NCT06824493
- Acronym / sponsor ID
- XJKQLY202503
- Conditions
- Orthodontics, White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, Caries, Dental
- Keywords
- microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ID number | – | Other: no interventions, Other: None-placebo, Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A description of the population from the population undergoing oral health examinations in primary schools
Key inclusion criteria (5 listed)
- No carries and White spot
- No missing teeth
- No history of oral treatment
- No malocclusion
- No systemic diseases
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionsno intervention as this is an observational studies | Other | ID number |
| None-placeboObservational study with no interventions | Other | ID number |
| No Intervention: Observational Cohortno intervention because of observational studies | Other | ID number |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontics and White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Dai (86+15319976663, daishanshan0723@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.