Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-31 @ 4:08 PM
Study NCT ID:
NCT06044766
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Root Form Classification of Impacted Lower Third Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-09-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of discrepancies and agreements on the classified root forms', 'timeFrame': 'Before surgical exatration', 'description': 'To report the radiographic classifications of root forms by two examiners'}, {'measure': 'Frequency of discrepancies and agreements on the classified root forms', 'timeFrame': 'Immidiately after extraction', 'description': 'To report the clinical classifications of root forms'}], 'secondaryOutcomes': [{'measure': 'The frequency of root types', 'timeFrame': 'Immediately after extraction', 'description': 'The frequency of fused roots and separated roots'}, {'measure': 'The frquency of fused root forms', 'timeFrame': 'Immediately after extraction', 'description': 'The frequency of the four fused roots forms'}, {'measure': 'The frequency of separated root forms', 'timeFrame': 'Immediately after extraction', 'description': 'The frequency of the six separated root forms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impacted lower third olars', 'Roots morphology', 'Root forms'], 'conditions': ['Impacted Lower Third Molars Roots']}, 'descriptionModule': {'briefSummary': 'A clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by Abu-Mostafa N (2023) The root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after extraction, and the identified root classifications will be compared.', 'detailedDescription': 'According to Abu-Mostafa N, the roots of impacted lower third molars are classified into two types: Fused roots and separated roots. Both have different forms:\n\nFused roots forms: Straight, Curved distal, Curved mesial, and S-shaped.\n\nSeparated roots forms: Straight, Both roots are curved distal, Both roots are curved mesial, Joined roots, One root is straight and one is curved, and More than two roots.\n\nA panoramic radiograph will be taken before extraction, then the roots will be classified by two Oral biologist and Oral and Maxillofacial Surgeon individually. After surgical extraction of the third molar, the roots will be examined clinically and classified according to the same classification.\n\nThe two pre-extraction radiographic classifications will be compared together, and then they will be compared with the clinical classification to check if there is a discrepancy.\n\nThe surgical extraction procedure:\n\nLocal anesthesia will be achieved by inferior alveolar nerve block and buccal infiltration using Lidocaine 2% with Epinephrine 1:100,000. A flap with a distobuccal releasing incision will be done. The bone reduction will be performed by a low-speed surgical handpiece under irrigation with normal saline. Root separation is done of required for the third molars with separated root forms. The tooth will be luxated by straight elevators and then extracted.\n\nThe evaluation results will be categorized to:\n\n* Agreement: The two pre-extraction radiographic evaluations and the clinical evaluations are similar\n* Discrepancy 1: One pre-extraction radiographic evaluation and the clinical evaluations are similar, but the other radiographic evaluation differs.\n* Discrepancy 2: the two pre-extraction radiographic evaluations are similar, but the clinical evaluation differs.\n* Disagreement: The three evaluations are different\n\nThe results will be analyzed regarding frequencies and association of each category with root forms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with impacted lower third molars who visit Riyadh Elm University" hospital and have lower third molars which are diagnosed clinically and radiographically as partially or fully impacted. The roots of these third molars have to be fully formed.\n\nExclusion Criteria:\n\nincomplete apex formation and root resorption'}, 'identificationModule': {'nctId': 'NCT06044766', 'briefTitle': 'Verification of the Root Form Classification of Impacted Lower Third Molars', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'A Clinical Study to Verify the Reliability of Root Form Classification of Impacted Lower Third Molars', 'orgStudyIdInfo': {'id': 'REU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgical exatrction of impacted lower third molars', 'description': 'Clinical intervention: Surgical exatrction of impacted lower third molar to examine and classify the roots, then to compare it with radiographic classification', 'interventionNames': ['Procedure: Surgical exatrction of impacted lower third molars']}], 'interventions': [{'name': 'Surgical exatrction of impacted lower third molars', 'type': 'PROCEDURE', 'description': 'Surgical exatrction of impacted lower third molars to verify the form of the root', 'armGroupLabels': ['Surgical exatrction of impacted lower third molars']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nedal A Abu-Mostafa, Assistant Professor', 'role': 'CONTACT', 'email': 'nabumostafa@gmail.com', 'phone': '+966506275782'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Colleges of Dentistry and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Oral and Maxillofacial Surgery', 'investigatorFullName': 'Nedal Abu-Mostafa', 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}