Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 11:24 AM
Study NCT ID:
NCT05573295
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2022-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation coefficient of Willems method', 'timeFrame': 'day 1', 'description': 'Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient'}, {'measure': 'Correlation coefficient of London Atlas method.', 'timeFrame': 'day 1', 'description': 'Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.'}, {'measure': 'Correlation coefficient of Cameriere European formula.', 'timeFrame': 'day 1', 'description': 'Dental age of children with Cleft Lip and Palate and healthy controls assessed by the correlation coefficient.'}], 'secondaryOutcomes': [{'measure': 'Dental age estimation in children with Cleft Lip and Palate', 'timeFrame': 'day 1', 'description': 'Dental age estimation in Turkish children'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'dental age estimation', 'Cleft Lip and Palate', 'chronological age', 'London Atlas', 'Cameriere European Formula', 'Willems method'], 'conditions': ['Dental Age Estimation', 'Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether there is a significant difference in dental age between children with CLP and healthy controls using the Willems method, Cameriere European formula and London Atlas. It is aimed to create a new formula if there is a significant difference in dental age between children with CLP and healthy controls.', 'detailedDescription': "Dental age is widely evaluated by pedodontists, forensic dentists and orthodontists. While a delay in tooth development may be associated with growth retardation and learning difficulties, dental age determination can also be used for forensic age determination for children whose birth information is uncertain. A clear assessment of maturation in children with continued growth is important in establishing a dental treatment plan.\n\nThere are two basic approaches to dental age determination in children:\n\nevaluation of eruption of teeth in the oral cavity, evaluation of the development and mineralization of crowns and roots on dental radiographs.\n\nIn many methods, the developmental stages of different numbers of permanent teeth are used.\n\nThe most commonly used method for determining dental age in children; is the Demirjian method that evaluates the development of seven left permanent mandibular teeth in eight stages (from A to H). Willems et al. In 2001, they modified the Demirjian method by conducting a study on the fact that it showed higher age determination in the Belgian Caucasian population. The adapted method was named the Willems method. It is stated that one of the advantages of this method is that it is a relatively simple system for determining tooth age.\n\nOne of the most widely used methods of dental age determination recently is the European formula of Cameriere et al., which is calculated based on open apex. It has been reported that this method has been tested on different population groups, and the results are accurate and reliable.\n\nAn atlas method was proposed by a group of London researchers in 2010. The Atlas shows all the teeth array images of certain age groups as a schematic series. Age determination is made by deciding which reference image matches the individual's panoramic radiography image more."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was conducted on gender-age matched healthy control group of children aged 5-14 years, who applied to Istanbul University Faculty of Dentistry, Department of Pedodontics, had an AI record in their anamnesis, had panoramic radiographs in the archive of the Department of Oral and Maxillofacial Radiology, Istanbul University Faculty of Dentistry.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5-14 years old\n* Healthy children\n* Children with CLP\n* Patients without missing left mandibular permanent teeth on panoramic radiography\n\nExclusion Criteria:\n\n* Children younger than 5 years old and older than 14 years (children that cannot be assessed by the Willems and Cameriere method)\n* Poor quality panoramic radiography\n* Patients who have received orthodontic treatment\n* Patients who received restorative or endodontic treatment'}, 'identificationModule': {'nctId': 'NCT05573295', 'briefTitle': 'Dental Age Estimation by Different Methods in Patients With Cleft Lip and Palate', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Evaluation of Dental Age of Children With Cleft Lip and Palate Using Willems Method, Cameriere European Formula, and London Atlas', 'orgStudyIdInfo': {'id': '2021/68'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with CLP', 'interventionNames': ['Other: Diagnostic Test: Willems method', 'Other: Diagnostic Test: Cameriere method', 'Other: Diagnostic Test: London Atlas method']}, {'label': 'Healthy controls with gender-age match', 'interventionNames': ['Other: Diagnostic Test: Willems method', 'Other: Diagnostic Test: Cameriere method', 'Other: Diagnostic Test: London Atlas method']}], 'interventions': [{'name': 'Diagnostic Test: Willems method', 'type': 'OTHER', 'description': "Willems method measures the developmental stages of the seven left permanent mandibular teeth and is frequently used for dental age estimation. The score of each stage is allocated, and the sum of the scores provides an evaluation of the subject's dental maturity.", 'armGroupLabels': ['Children with CLP', 'Healthy controls with gender-age match']}, {'name': 'Diagnostic Test: Cameriere method', 'type': 'OTHER', 'description': 'Cameriere et al. designed a quantitative approach through a formula based on sex and the ratio between length and apex opening measurements of each lower left tooth.', 'armGroupLabels': ['Children with CLP', 'Healthy controls with gender-age match']}, {'name': 'Diagnostic Test: London Atlas method', 'type': 'OTHER', 'description': 'The London Atlas requires the user to assess the tooth development and eruption and then match it to one of the 31 pictures of age categories.', 'armGroupLabels': ['Children with CLP', 'Healthy controls with gender-age match']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yelda Kasimoglu Eldem, Assoc. Prof.', 'role': 'CONTACT'}], 'facility': 'Istanbul University, Faculty of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Yelda Kasimoglu Eldem, Assoc. Prof.', 'role': 'CONTACT', 'email': 'yelda.kasimoglu@istanbul.edu.tr', 'phone': '00905336233978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yelda Kasımoğlu', 'investigatorAffiliation': 'Istanbul University'}}}}