Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04817358
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2021-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Influences on Dental Maturation: A Twin Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-25', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nolla method', 'timeFrame': 'up to 3 years', 'description': 'In the Nolla method, the development of seven left mandibular and maxillar teeth were defined on 10 stages. If the tooth was between stages an appropriate fraction (0.2, 0.5 or 0.7) was added. The total score was determined according to the tables prepared for girls and boys as recommended by Nolla'}], 'primaryOutcomes': [{'measure': 'Demirjian method', 'timeFrame': 'up to 3 years', 'description': 'the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls'}], 'secondaryOutcomes': [{'measure': 'Willems method', 'timeFrame': 'up to 3 years', 'description': "Willems' method was determined using the Demirjian calcification stages but scores were evaluated according to Willems' specific tables"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Age Estimation Methods']}, 'descriptionModule': {'briefSummary': "The genetics has been shown as one of the most important factor influencing the growth and development of the dentofacial complex. Dental development, one of the most reliable indicators of chronological age (CA), has been believed to be fundamentally influenced by genetics rather than environmental factors. As twins share genetic variation (100% for monozygotic and 50% for dizygotic twins) and were subjected to the similar environmental factors, the twin studies have been presented useful and effective method to researchers for investigating the influence of heredity on dental development and observing the similarities and differences among twin pairs.\n\nEvaluation of dental development is among the most commonly used and reliable method for dental age determination using the morphological parameters of teeth on dental radiographs. Dental maturity, defined as a dental age (DA), is very important in forensic anthropology to identify cases and in dentistry for planning pedodontic and orthodontic treatment, and also determining a child's growth and developmental status.\n\nThere are many dental age estimation methods which are mostly based on the morphological evaluation of dental growth observed from dental radiographs in children In order to estimate dental age, Demirjian's, Willems' and Nolla's methods were used. All panoramic radiographs were scored by one observer to eliminate the inter-observer error."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of MZ and DZ pairs between the ages of 5.0 and 12.9 who attended to the Department of Pedodontics at Suleyman Demirel University and underwent radiological examination for any dental reason during the dental treatment period from January 2018 to January 2021', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good quality of panoramic radiographs, presence of all permanent mandibular and maxillar teeth except the third molars\n* healthy children with normal eruption of teeth,\n* children with similiar etnic origin and socio-economic status\n\nExclusion Criteria:\n\n* Children with any syndromes, congenital or developmental anomalies and systemic diseases,\n* Children undergoing or with previous orthodontic treatment history,\n* Children with tooth agenesis, dental trauma history'}, 'identificationModule': {'nctId': 'NCT04817358', 'briefTitle': 'Genetic Influences on Dental Maturation: A Twin Study', 'organization': {'class': 'OTHER', 'fullName': 'Suleyman Demirel University'}, 'officialTitle': 'Genetic Influences on Dental Maturation: A Twin Study', 'orgStudyIdInfo': {'id': '2018/232'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Demirjian method', 'description': 'According to the Demirjian method, the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls'}, {'label': 'Willems method', 'description': "Willems' method was determined using the Demirjian calcification stages but scores were evaluated according to Willems' specific tables"}, {'label': 'Nolla method', 'description': 'In the Nolla method, the development of seven left mandibular and maxillar teeth were defined on 10 stages. If the tooth was between stages an appropriate fraction (0.2, 0.5 or 0.7) was added. The total score was determined according to the tables prepared for girls and boys as recommended by Nolla'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Suleyman Demirel University Faculty of Dentistry', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suleyman Demirel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Esra Oz', 'investigatorAffiliation': 'Suleyman Demirel University'}}}}