Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06283602
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Health in Children and Adolescents With Obesity and Normal Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the results of DMFT, plaque and gingival indies', 'timeFrame': '12 months', 'description': 'The results of the study indicate that individuals with obesity tend to exhibit significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight t significantly higher scores for DMFT, plaque, and gingival index as compared to those with normal weight (p\\<0.05)'}, {'measure': 'the results of dmft, BEWE, ICDAS-II, probing dept', 'timeFrame': 'up to 12 months', 'description': 'No significant difference was observed concerning dmft and other factors (p\\>0.05)'}, {'measure': 'Comparison of demographic attributes between obese and normal weights', 'timeFrame': '12 months', 'description': "Significant disparities were identified between patients with normal weight and those who were obese, particularly in BMI, income, and tooth brushing habits. Obese patients exhibited considerably higher BMI scores in comparison to those with normal weight (p\\<0.001).Body mass index (BMIs; kg/m2) was calculated by the pediatrician using the patients' height (meters) and weight (kilograms). BMI 5-85th percentile normal weight according to gender and age; BMI 85- 95 percentile overweight; Those at the 95th percentile and above were considered obese"}], 'secondaryOutcomes': [{'measure': 'biochemical parameters of obese individuals', 'timeFrame': '11 months', 'description': 'Procalcitonin exhibited significantly negative correlation between DMFT and ICDAS-II (p\\<0.05).'}, {'measure': 'other biochemical parameters of obese individuals', 'timeFrame': 'up to 11 months', 'description': 'No significant correlation was found between the biomarkers and other investigated factors (p\\>0.05)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental caries', 'periodontal health', 'children', 'obesity', 'erosive tooth wear'], 'conditions': ['Pediatric Obesity', 'Pediatric Dentistry']}, 'descriptionModule': {'briefSummary': 'We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.\n\n82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD).', 'detailedDescription': 'Also, the relationship between procalcitonin (PCT), C-reactive protein (CRP), parathormone (PTH), and 25(OH)D blood biochemistry and oral health was evaluated in obese children/adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 6-16 years obesity children and adolescents\n\n* 6-16 years healthy children and adolescents\n\nExclusion Criteria:\n\n* Infection,\n* diabetes, leukemia, asthma, bronchitis, cognitive neuromotor disorder, hormonal disease'}, 'identificationModule': {'nctId': 'NCT06283602', 'briefTitle': 'Oral Health in Children and Adolescents With Obesity and Normal Weight', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Erosive Tooth Wear, Caries Experience and Periodontal Health in Children and Adolescents With Obesity and Normal Weight', 'orgStudyIdInfo': {'id': '2020/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Kahramanmaraş Sütçü İmam University', 'description': 'Patient who apply to our clinic for routine paediatric treatment for the included in the study', 'interventionNames': ['Diagnostic Test: oral health status']}], 'interventions': [{'name': 'oral health status', 'type': 'DIAGNOSTIC_TEST', 'description': 'the dentists examined the dried teeth with a probe and mount mirror in a dental unit.', 'armGroupLabels': ['Kahramanmaraş Sütçü İmam University']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Aslı Soğukpınar Önsüren', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Aslı Sogukpınar', 'investigatorAffiliation': 'Mersin University'}}}}