Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 6:47 AM
Study NCT ID:
NCT06372366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Manifestations in Egyptian Children With Short Stature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009912', 'term': 'Oral Manifestations'}, {'id': 'D004392', 'term': 'Dwarfism'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental enamel defects', 'timeFrame': '3 months', 'description': "using Aine's classification"}, {'measure': 'Delayed dental eruption', 'timeFrame': '3 months', 'description': 'using Dental eruption table'}, {'measure': 'Malocclusion', 'timeFrame': '3 months', 'description': 'using Angle classification'}, {'measure': 'Dental caries experience', 'timeFrame': '3 months', 'description': 'using def+DMF'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Manifestations', 'Short Stature']}, 'descriptionModule': {'briefSummary': 'Children with short stature have been reported to show a higher prevalence of enamel hypoplasia, delayed tooth eruption, and malocclusion compared to children of normal growth status', 'detailedDescription': 'Normal growth is a process in which a single cell develops into a fully grown adult. The growth rate decelerates from the embryonic stage to adulthood, except during puberty. Most adults fall within a narrow range of stature, typically between 1.5 to 2 meters. Variations in height among children are largely determined by a set of genes inherited from their parents. These genes influence stature distribution within the normal range for nearly 95% of the population, with variation generally being benign.\n\nShort stature in children-defined as a height-for-age below -2 standard deviations (SD) from the WHO growth reference-typically corresponding to the 2.3rd percentile, though many texts use the 3rd percentile as the cutoff. Short stature can be assessed using various anthropometric instruments. The condition may be physiological, with no abnormalities other than stature (polygenic short stature), or pathological, resulting from systemic illnesses, nutritional deficiencies, psychosocial factors, hormonal imbalances, genetic disorders, or musculoskeletal pathologies. A subset of infants born small for gestational age (SGA) may be at risk of persistent short stature.\n\nChildren with short stature have been reported to show a higher prevalence of enamel hypoplasia, delayed tooth eruption, and malocclusion compared to children of normal growth status . These oral manifestations may result from shared pathogenic mechanisms, such as nutritional deficits, systemic disturbances during enamel formation, or hormonal imbalances affecting growth and development. A clearer understanding of these associations may enhance multidisciplinary screening and care.\n\nThis study aims to investigate the prevalence and characteristics of oral manifestations in Egyptian children with short stature, contributing to the limited regional data on this topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged from 6 to 12 years attending National Nutrition Institute will be included in the study according to the following criteria:', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • - Egyptian children aged 6-12 years.\n* \\- Diagnosed with short stature (height-for-age \\< -2 SD based on WHO standards).\n* \\- Diagnosed and confirmed by a pediatric endocrinologist.\n\nControls:\n\n* \\- Age- and sex-matched children with normal height (height-for-age between -1 and +1 SD).\n* \\- Recruited from the same geographic and socioeconomic backgrounds.\n\nExclusion Criteria:\n\n* 1- Presence of syndromic conditions (e.g., Turner syndrome, Down syndrome).\n* 2- Chronic diseases (e.g., renal, cardiac, or endocrine conditions other than idiopathic short stature).\n* 3- Long-term medication use known to affect growth or oral development.'}, 'identificationModule': {'nctId': 'NCT06372366', 'briefTitle': 'Oral Manifestations in Egyptian Children With Short Stature', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Oral Manifestations in a Group of Egyptian Children With Short Stature and a Group of Healthy Egyptian Children : A Cross Sectional Study', 'orgStudyIdInfo': {'id': 'Oral signs ,short stature'}}, 'armsInterventionsModule': {'armGroups': [{'label': '17children with short stature'}, {'label': '17 normal children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal researcher (Dentist)', 'investigatorFullName': 'Nada Soliman Abd El-Ghaffar Abd El-Megid Abd Allah', 'investigatorAffiliation': 'Cairo University'}}}}