Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-26 @ 3:42 PM
Study NCT ID:
NCT04675203
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Mechanisms of Tooth Eruption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005076', 'term': 'Exanthema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014081', 'term': 'Tooth Extraction'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'teeth and bone fragments of the jaw'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression and localization of molecules involved in tooth eruption', 'timeFrame': 'During surgery', 'description': 'Tissues are collected at the time of surgery and transferred during the day to the laboratory for analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Eruption']}, 'descriptionModule': {'briefSummary': 'The main objective is to study the expression of molecules involved in tooth morphogenesis and eruption in healthy patients, and then to compare them with the results in patients with abnormalities of eruption (results obtained via a collection of biological samples of rare diseases already authorized).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic (Hôpitaux Universitaires de Strasbourg, France)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 12 years old who has given his consent\n* Patient whose legal representatives have given their consent for the use of operating waste destined for incineration\n* Patient undergoing oral surgery at the University Hospitals of Strasbourg, at the origin of the production of surgical waste such as teeth and bone fragments\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Refusal to participate\n* Patient with chronic systemic pathology\n* Patient under long-term drug treatment\n* Patient presenting a rare pathology with oral manifestation\n* Patient with a history of chemotherapy or head and neck radiotherapy\n* Non-French speaking patient / inability to give informed information\n* Patient under guardianship, curatorship or legal protection'}, 'identificationModule': {'nctId': 'NCT04675203', 'briefTitle': 'Molecular Mechanisms of Tooth Eruption', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Molecular Mechanisms of Tooth Eruption', 'orgStudyIdInfo': {'id': '7946'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal tooth eruption', 'interventionNames': ['Procedure: Tooth extraction']}], 'interventions': [{'name': 'Tooth extraction', 'type': 'PROCEDURE', 'description': 'Tooth extraction', 'armGroupLabels': ['Normal tooth eruption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Marion STRUB', 'role': 'CONTACT', 'email': 'marion.strub@chru-strasbourg.fr', 'phone': '+33 3 88 69 56'}, {'name': 'Marion STRUB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Marion STRUB', 'role': 'CONTACT', 'email': 'marion.strub@chru-strasbourg.fr', 'phone': '+33 3 88 69 56'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}