Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06824493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orthodontic Treatment on Oral Microbiota and Salivary Proteins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2025-01-11', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota changes of plaque', 'timeFrame': '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.', 'description': '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'}, {'measure': 'Microbiota changes of saliva', 'timeFrame': 'Baseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.', 'description': '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'}, {'measure': 'Monitoring dental lesion progression', 'timeFrame': 'Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiota'], 'conditions': ['Orthodontics', 'White Spot Lesions [Initial Caries] on Smooth Surface of Tooth', 'Caries, Dental']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A description of the population from the population undergoing oral health examinations in primary schools', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No carries and White spot\n* No missing teeth\n* No history of oral treatment\n* No malocclusion\n* No systemic diseases\n\nExclusion Criteria:\n\n* Antibiotic use in the past three months\n* A history of long-term medication use\n* A history of dental fillings\n* Unable to attend regular follow-ups'}, 'identificationModule': {'nctId': 'NCT06824493', 'briefTitle': 'Orthodontic Treatment on Oral Microbiota and Salivary Proteins', 'organization': {'class': 'OTHER', 'fullName': "Xi'an Jiaotong University"}, 'officialTitle': 'Orthodontic Treatment on Oral Microbiota and Salivary Proteins', 'orgStudyIdInfo': {'id': 'XJKQLY202503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ID number', 'interventionNames': ['Other: no interventions', 'Other: None-placebo', 'Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'no interventions', 'type': 'OTHER', 'description': 'no intervention as this is an observational studies', 'armGroupLabels': ['ID number']}, {'name': 'None-placebo', 'type': 'OTHER', 'description': 'Observational study with no interventions', 'armGroupLabels': ['ID number']}, {'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'no intervention because of observational studies', 'armGroupLabels': ['ID number']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shan shan Dai', 'role': 'CONTACT', 'email': 'daishanshan0723@163.com', 'phone': '86+15319976663'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician of pediatric dentist and PhD in Orthodontics', 'investigatorFullName': 'Shanshan-Dai', 'investigatorAffiliation': "Xi'an Jiaotong University"}}}}