Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-29 @ 7:45 AM
Study NCT ID:
NCT05779332
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2023-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D003741', 'term': 'Dental Deposits'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003945', 'term': 'Diagnosis, Oral'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the prevalence and etiology of MIH.', 'timeFrame': 'up to four months', 'description': 'A questionnaire was applied to the parents about the etiological factors and the prevalence of MIH was determined by oral examination.'}, {'measure': 'To evaluate the impacts of MIH on oral health status.', 'timeFrame': 'up to six months', 'description': 'Oral health was evaluated by recording dmft (decayed, missing and filled teeth) and plaque index values.'}, {'measure': 'To evaluate the impacts of MIH on OHRQoL.', 'timeFrame': 'up to six months', 'description': 'The impact of MIH on quality of life (OHRQoL) was measured with the Child Perception Questionnaire (CPQ8-10).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Molar Incisor Hypomineralization', 'oral health', 'MIH', 'Oral health related lif quality', 'Child Perceptions Questionnaire', 'OHRQoL', 'CPQ'], 'conditions': ['Molar Incisor Hypomineralization', 'Oral Health', 'Child, Only', 'Pediatric ALL', 'Dental Caries', 'Dental Plaque', 'Dental Diseases']}, 'descriptionModule': {'briefSummary': 'Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).', 'detailedDescription': "Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL.\n\nSix hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p\\<0.05 was statistical significant.\n\n."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '9 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 9-year-old,\n* Mentally and physically capable of completing the questionnaire,\n* Presence of fully erupted 4 permanent molars and 8 permanent incisors.\n\nExclusion Criteria:\n\n* Children were receiving orthodontic treatment during the examination,\n* Children had enamel hypoplasia or developmental defects,\n* Children had amelogenesis imperfecta or dental fluorosis.'}, 'identificationModule': {'nctId': 'NCT05779332', 'briefTitle': 'Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University Training and Research Hospital'}, 'officialTitle': 'Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization: A Comprehensive Study', 'orgStudyIdInfo': {'id': '140'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey application', 'type': 'OTHER', 'otherNames': ['oral examination'], 'description': "Children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Sema Aydinoğlu', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Sema Aydınoglu', 'investigatorAffiliation': 'Recep Tayyip Erdogan University Training and Research Hospital'}}}}