Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06359093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1532}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-04-06', 'studyFirstSubmitQcDate': '2024-04-06', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.', 'timeFrame': 'Day 1', 'description': 'clinical examination'}], 'secondaryOutcomes': [{'measure': 'Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions.', 'timeFrame': 'Day 1', 'description': 'questionnaire will be used to collect data. For quantitative analysis of saliva: if saliva flow rate is less than 1ml/min , it is considered xerostomia.\n\nIf saliva flow rate is less than 1ml/min , it is low salivary flow if saliva flow rate is more than 3, it is high salivary flow'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient-related risk factors'], 'conditions': ['Non-carious Cervical Lesions']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the flow rate and pH of saliva, as one of the potential etiological factors, will be assessed.', 'detailedDescription': 'Dental patients will be recruited from diagnostic central clinic at the Cairo University Dental Educational Hospital. Oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be filled by patients including age, gender, occupation, education, place of residence, toothbrushing: included frequency, method, intensity, hardness and duration, biting and chewing habits, medical history \\[related to gastrointestinal problems such as belching, heartburn, vomiting, gastro-oesophageal reflux (GER), peptic ulcer disease\\], eating disorders (anorexia, bulimia), medication list, frequency of consuming acidic food and fruits, carbonated beverages and alcohol and smoking status. Salivary assessment regarding flow rate and pH for a subgroup diagnosed with non-carious cervical lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '41 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients whose age between 41-60 years old.\n2. Patient consulting in the outpatient clinic\n3. Provide informed consent.\n4. Males \\& Females\n5. Egyptian\n\nExclusion Criteria:\n\n1. Patients under or over this age group.\n2. Refuse to participate in the study.\n3. Wearing orthodontic appliance.\n4. The presence of trismus.'}, 'identificationModule': {'nctId': 'NCT06359093', 'briefTitle': 'Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients Attending the Cairo University Dental Educational Hospital: Analytical Cross-Sectional Study', 'orgStudyIdInfo': {'id': '14422023557605'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rowayda Anwar Eltarawy, MSc', 'role': 'CONTACT', 'email': 'rowayda.anwar@dentistry.cu.edu.eg', 'phone': '+201066517727'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Rowayda Anwar Hosny Eltarawy', 'investigatorAffiliation': 'Cairo University'}}}}