Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 9:31 PM
Study NCT ID:
NCT05156359
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Idiopathic Scoliosis and Orthodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the frequency of wearing orthodontic treatment in idiopathic scoliosis adolescents, and compare it with that of adolescents without spinal dysmorphism.', 'timeFrame': 'Files analysed retrospectively from January 01, 2020 to August 31, 2020 will be examined]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic scoliosis', 'Orthodontic Treatment', 'spinal dysmorphism'], 'conditions': ['Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.\n\nThe aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children (age ≥ 12 years) with idiopathic scoliosis confirmed by X-ray.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult and child (age ≥ 12 years)\n* Be carriers of idiopathic scoliosis confirmed by X-ray.\n* Have reached bone maturity (Risser 4 and more)\n* Adult who has not expressed, after information, the reuse of his data for the purposes of this research\n* \\- Child and Holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research\n\nExclusion criteria:\n\n* Refusal to participate in the study\n* Association with another orthopedic pathology\n* Adult patients under guardianship or crater or under the protection of justice'}, 'identificationModule': {'nctId': 'NCT05156359', 'acronym': 'SITO', 'briefTitle': 'Idiopathic Scoliosis and Orthodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Idiopathic Scoliosis and Orthodontic Treatment', 'orgStudyIdInfo': {'id': '8049'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}