Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT06506734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D001656', 'term': 'Biliary Atresia'}, {'id': 'C535933', 'term': 'Cholestasis, progressive familial intrahepatic 1'}, {'id': 'D016738', 'term': 'Alagille Syndrome'}, {'id': 'D014075', 'term': 'Tooth Discoloration'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D015903', 'term': 'Moire Topography'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D010780', 'term': 'Photogrammetry'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007368', 'term': 'Interferometry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life score by patient group', 'timeFrame': 'through study completion, an average of 18 months', 'description': "Assess the quality of life score based on the patient's group classification"}], 'primaryOutcomes': [{'measure': 'Prevalence of dental dyschromia', 'timeFrame': 'from birth to study completion, a maximum of 19 years', 'description': 'presence of dyschromia or not evaluated by 2 investigators'}], 'secondaryOutcomes': [{'measure': 'Presence or absence of dental dyschromia', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'Presence or absence of dental dyschromia based on various variables such as bilirubin levels or the duration of hyperbilirubinemia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperbilirubinemia', 'Biliary Atresia', 'Progressive Familial Intrahepatic Cholestasis (PFIC)', 'Alagille Syndrome', 'Tooth Discoloration'], 'conditions': ['Dental Diseases']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years. The study will also examine risk factors associated with this condition, such as the duration and severity of hyperbilirubinemia, underlying diseases, and treatments received.\n\nThe researchers hypothesize that the quality of life of individuals with dental dyschromia is lower than that of individuals without dyschromia. The results of this study will be used to discuss coverage for dental care with health insurance for children affected by this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 12 to 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient with biliary atresia, progressive familial intrahepatic cholestasis, or Alagille syndrome\n* Patient or legal representative not opposed to participating in this research.\n\nExclusion Criteria:\n\n* Inability to understand and respond to quality of life questionnaires'}, 'identificationModule': {'nctId': 'NCT06506734', 'acronym': 'SMILE', 'briefTitle': 'Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Prevalence of Dental Dyschromia and Impact on the Quality of Life of Participants with Prolonged Hyperbilirubinemia During Their Early Years', 'orgStudyIdInfo': {'id': 'RC31/23/0443'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dental Dyschromia in Hyperbilirubinemia Patients', 'description': '30 minutes', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'otherNames': ['Photograph'], 'description': '* " Psychosocial Impact of Dental Aesthetics Questionnaire " PMID 24280547\n* " Orofacial Esthetic Scale " PMID 30856637\n* " Orofacial Esthetic Scale " PMID 34231057\n* A photograph of the patient\'s smile will be sent to 2 dentists who will also assess the presence or absence of dental dyschromia.', 'armGroupLabels': ['Dental Dyschromia in Hyperbilirubinemia Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'University Hosptial Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'country': 'France', 'facility': 'University Hospital Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'University Hospital Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, FHU Hépatinov', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique-Hôpitaux de Paris, Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'University Hospital Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Nolwenn LABORDE, MD', 'role': 'CONTACT', 'email': 'laborde.n@chu-toulouse.fr', 'phone': '05 61 77 96 70'}, {'name': 'Romain LOPEZ, PharmD', 'role': 'CONTACT', 'email': 'lopez.ro@chu-toulouse.fr'}], 'overallOfficials': [{'name': 'Nolwen LABORDE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}