Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05779618
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Tongue Anomalies in Egyptian Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D000072676', 'term': 'Ankyloglossia'}, {'id': 'D014063', 'term': 'Tongue, Fissured'}, {'id': 'D005929', 'term': 'Glossitis, Benign Migratory'}, {'id': 'D008260', 'term': 'Macroglossia'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D005928', 'term': 'Glossitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of tongue anomalies', 'timeFrame': '1 month', 'description': 'studying the prevalence of tongue anomalies among Egyptian children between 6 to 12 years old'}], 'secondaryOutcomes': [{'measure': 'macroglossia, microglossia and ankyloglossia effect on occlusion', 'timeFrame': '1 month', 'description': 'detecting the presence or absence of malocclusion in cases of three types of tongue anomalies (ankyloglossia, macroglossia and microglossia)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tongue anomalies', 'ankyloglossia', 'Fissured tongue', 'Geographic tongue', 'macroglossia'], 'conditions': ['Tongue; Anomaly']}, 'referencesModule': {'references': [{'pmid': '16264385', 'type': 'BACKGROUND', 'citation': 'Rioboo-Crespo Mdel R, Planells-del Pozo P, Rioboo-Garcia R. Epidemiology of the most common oral mucosal diseases in children. Med Oral Patol Oral Cir Bucal. 2005 Nov-Dec;10(5):376-87. English, Spanish.'}, {'pmid': '19656020', 'type': 'BACKGROUND', 'citation': 'Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086.'}, {'pmid': '30152627', 'type': 'BACKGROUND', 'citation': 'Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708.'}, {'pmid': '12974518', 'type': 'BACKGROUND', 'citation': 'Avcu N, Kanli A. The prevalence of tongue lesions in 5150 Turkish dental outpatients. Oral Dis. 2003 Jul;9(4):188-95. doi: 10.1034/j.1601-0825.2003.02933.x.'}, {'pmid': '32766305', 'type': 'BACKGROUND', 'citation': 'Chang PS, Yen TH, Huang CJ, Yen AM, Chen SL, Tsai AI. Clinical Orodental Anomalies in Taiwanese Children under Age Six: a Study Based on the 1995-1997 National Dental Survey. Biomed Res Int. 2020 Jul 19;2020:2056340. doi: 10.1155/2020/2056340. eCollection 2020.'}, {'pmid': '26156909', 'type': 'BACKGROUND', 'citation': 'Rezaei F, Safarzadeh M, Mozafari H, Tavakoli P. Prevalence of Geographic tongue and Related Predisposing Factors in 7-18 Year-Old Students in Kermanshah, Iran 2014. Glob J Health Sci. 2015 Feb 24;7(5):91-5. doi: 10.5539/gjhs.v7n5p91.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the prevalence of tongue anomalies in a group of Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue tie and microglossia.', 'detailedDescription': 'The tongue is an important and accessible muscle in the oral cavity, it has many functions which includes speech, chewing, swallowing, sucking, control of breathing, growth and developments of the jaws and perception to pain.\n\nAlso, many systemic disorders and diseases affect the tongue which makes it a great reflector of the general health.\n\nTongue anomalies has different frequencies and prevalence between different countries, these differences may be due to geographic, ethnic, gender and age variability, for example a study in Iran in 2003 found that the prevalence of tongue anomalies 34.3%, while another study in Colombia in 2013 found that the prevalence of tongue anomalies on their study population was 79.9%.\n\nThe knowledge of the prevalence of tongue anomalies among Egyptian children is missing in the literature which could compromise the quality of dental care, increase the occurrence of orthodontic problems and decrease the chances of early detection of some systemic diseases, since tongue anomalies could help in early determination of some systemic diseases in cases of fissured tongue and geographic tongue as well as early prevention and early intervention of malocclusions and speech defects that might be caused in cases of microglossia, macroglossia and ankyloglossia.\n\nHence, the knowledge of prevalence of tongue anomalies among Egyptian children can aid in setting a reference which will then help in public health planning and prevention policies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'school children between six to twelve years old', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants' age between 6-12 years.\n* Co-operative child\n* Positive participants' acceptance for participation in the study.\n* Participants having responsible care giver answered by approval on the previously sent informed consent which describes the aim \\& importance of the study\n\nExclusion Criteria:\n\n* Patients with history of significant medical conditions\n* Participants undertaken anti-fungal drugs in the previous 12 months"}, 'identificationModule': {'nctId': 'NCT05779618', 'briefTitle': 'Prevalence of Tongue Anomalies in Egyptian Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Tongue Anomalies Among Group of Egyptian Children: a Cross-sectional Study', 'orgStudyIdInfo': {'id': '120805'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'observational study, all data collected are binary'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Aley Ibn Abi Taleb primary school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mansheyet Gebril primary school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Randa Abd Al Gawad, Dental PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Yasmin Yousry, Dental PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'data will be available starting June 2023 for 1 year', 'ipdSharing': 'YES', 'description': 'Data to be shared via email to other researchers if needed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Aya Mostafa Mohamed Elzahaby', 'investigatorAffiliation': 'Cairo University'}}}}