Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT04857658
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2021-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'third molar angulation', 'timeFrame': 'at the end of orthodontic treatment', 'description': 'The angulation of the mandibular third molars'}], 'secondaryOutcomes': [{'measure': 'space available for the upper and lower third molar', 'timeFrame': 'at the end of orthodontic treatment', 'description': 'space available for the upper and lower third molar'}, {'measure': 'Angulation of the third molar.', 'timeFrame': 'at the end of orthodontic treatment', 'description': 'Angulation of the third molar.'}, {'measure': 'The vertical position of the third molars', 'timeFrame': 'at the end of orthodontic treatment', 'description': 'The vertical position of the third molars'}, {'measure': 'the mineralization status of the third molars', 'timeFrame': 'at the end of orthodontic treatment', 'description': 'the mineralization status of the third molars'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['third molar impaction, third molar angulation, third molar vertical position'], 'conditions': ['Orthodontic Treatment Via Premolar Extraction']}, 'descriptionModule': {'briefSummary': 'What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?', 'detailedDescription': 'Data regarding the personal information (name, age and gender), chief complaint, medical and dental history will be taken. Medical history questionnaire will be filled by the patient to exclude the presence of any systemic conditions.\n\ncomplete set of orthodontic records will be taken; Pre- operative records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \\& lateral cephalogram). After formulating the best treatment plan for each patient, All patients will be enrolled into one of two groups: Intervention Group (I) : Extraction treatment group. Comparator group (C): Non-extraction group. Following the end of treatment, Post-treatment records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \\& lateral cephalogram) will be taken.\n\nPrimary outcome: The angulation of the mandibular third molars.Secondary outcomes:\n\n1. space available for the upper and lower third molar.\n2. Angulation of the third molar.\n3. The vertical position of the third molars.\n4. the mineralization status of the third molars'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.\n\n * Dental Class I malocclusion cases requiring four premolar extraction with a moderate anchorage requirement.\n * low or increased vertical dimension.\n\nExclusion Criteria:\n\n* Premolar extraction cases requiring maximum anchorage preparation.\n\n * Low vertical dimension.\n * patients without dentofacial deformities, severe facial asymmetries, or missing teeth.'}, 'identificationModule': {'nctId': 'NCT04857658', 'briefTitle': 'Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars: A Non-Randomized Clinical Trial /a Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBD-CU-2021-10-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'extraction treatment', 'description': 'patients will be referred for extraction of the upper and lower first premolars to relieve the crowding.', 'interventionNames': ['Procedure: extraction orthodontic treatment plan']}, {'type': 'NO_INTERVENTION', 'label': 'non-extraction treatment', 'description': 'Leveling and alignment of the moderate crowding will be performed through a recall visits of 4 weeks for wire activation. inter-proximal reduction step might be done if needed.'}], 'interventions': [{'name': 'extraction orthodontic treatment plan', 'type': 'PROCEDURE', 'description': 'patients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow.', 'armGroupLabels': ['extraction treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12588', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Amira Aboalnaga', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'amira aboalnaga', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the pre-treatment and post-treatment records'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'amira ahmed aboalnaga', 'investigatorFullName': 'Amira Aboalnaga', 'investigatorAffiliation': 'Cairo University'}}}}