Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-25 @ 10:34 AM
Study NCT ID:
NCT06518733
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on the social and emotional well-being status of the patient.', 'timeFrame': 'during the intervention', 'description': 'impact social and emotional well-being status of the patient is assessed using a questionnaire'}], 'secondaryOutcomes': [{'measure': 'Impact on the oral health, pain, and discomfort of the respondent', 'timeFrame': 'during the intervention', 'description': 'Impact on the oral health, pain, and discomfort of the respondent is assessed using a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'This cross-sectional study aimed to investigate the impact of different fixed orthodontic appliances on the day-to-day life experience of adolescent patients at any stage of their orthodontic treatment. A validated questionnaire was translated and used in the assessment, 364 patients (242 female and 122 male) were recruited, impact on the social and emotional well-being status of the participants was assessed as well as oral health, pain, and discomfort.', 'detailedDescription': "This cross-sectional study aimed to evaluate the impact of orthodontic treatment on the daily life experience of adolescents wearing fixed orthodontic appliances. We aimed to assess the impact of different fixed orthodontic appliances in a sample of 364 patients either having labial fixed orthodontic appliances only or combined with palatal anchorage appliances, combined with mini-screws, combined with both palatal anchorage appliances and mini-screws or having fixed retainers. The outcomes were the impact on the patient's social and emotional well-being status and the impact on the patient's oral health, pain, and discomfort. a questionnaire was distributed and the patient was asked to fill it in. The questionnaire is composed of 22 questions with a 3-point scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian adolescent patients with age 13-18 with fixed orthodontic appliances', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients\n* Patients wearing fixed orthodontic appliances at any stage of treatment (labial fixed appliance only - labial fixed appliance combined with any palatal or lingual appliance - labial fixed appliance combined with mini-screws) or fixed retainers either in the upper arch only, lower arch only, or in both arches.\n* Age: 13-18 years old\n\nExclusion Criteria:\n\n* Patients who refused to participate in the study.\n* Patients with cleft lip or palate.\n* Illiterate patients.\n* Patients who had a complicated medical history.\n* Patients with severe skeletal discrepancy undergoing combined orthodontic and orthognathic surgical treatment.'}, 'identificationModule': {'nctId': 'NCT06518733', 'briefTitle': 'Orthodontic Treatment Impact on Life Experience of Adolescents With Fixed Orthodontic Appliances', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Orthodontic Treatment Impact on Day-to-Day Life Experience of Adolescents With Fixed Orthodontic Appliances: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '11543267'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'patients with fixed labial orthodontic appliance', 'interventionNames': ['Other: appliance type']}, {'label': 'Group B', 'description': 'patients with fixed labial appliance with palatal appliances', 'interventionNames': ['Other: appliance type']}, {'label': 'Group C', 'description': 'patients with fixed labial appliance with miniscrews', 'interventionNames': ['Other: appliance type']}, {'label': 'Group D', 'description': 'patients with fixed labial appliance with both palatal appliances and miniscrews', 'interventionNames': ['Other: appliance type']}, {'label': 'Group E', 'description': 'patients with fixed retainer', 'interventionNames': ['Other: appliance type']}], 'interventions': [{'name': 'appliance type', 'type': 'OTHER', 'description': 'different types of appliances: labial fixed appliances only, fixed retainers, palatal appliances and miniscrews', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master candidate', 'investigatorFullName': 'Shimaa Mohamed Gaber', 'investigatorAffiliation': 'Cairo University'}}}}