Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05436158
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2022-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-19', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'presence of the implant in the safe angle', 'timeFrame': '6 months', 'description': 'binary (Y/N) from CBCT'}, {'measure': 'use of angled or straight abutment', 'timeFrame': '6 months', 'description': 'Binary (straight/angled)'}], 'secondaryOutcomes': [{'measure': 'Pink Esthetic Score', 'timeFrame': '6 months', 'description': 'Pink Esthetic Score (1-14)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate dental implants', 'anterior maxilla', 'safe angle position'], 'conditions': ['Immediate Implant Placement', 'Esthetic Zone', 'Anterior Maxilla', 'Safe Angle Position']}, 'descriptionModule': {'briefSummary': 'There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).\n\nThe possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.\n\nThe aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.', 'detailedDescription': 'Immediate implants are implants inserted immediately after surgical extraction of the teeth to be replaced. Creation of an anatomically correct emergence profile is one of the most important aspects in providing an esthetically pleasing implant-supported restoration. Dentists understand the risks involved when restored prostheses are subjected to non-axial loading. It has always been recommended to direct occlusal loads as close to the long axis of the fixture as possible. However, it is known that the loading on angled abutments is mostly off-axis, which raises the concern of how angled abutments generally perform with such an unfavourable loading regimen.\n\nThere is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).\n\nThe possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.\n\nThe aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with immediate implants in the anterior region', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with immediate implants in the anterior region\n2. Patient with preoperative and postoperative CBCT\n3. Provide informed consent.\n\nExclusion Criteria:\n\n1. patients without a preoperative CBCT.\n2. 2- patients without an informed consent.'}, 'identificationModule': {'nctId': 'NCT05436158', 'briefTitle': 'The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Use of a New Safe Angle Position for Implant Placement in the Anterior Region: A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'IDCE.N2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implant placement in the safe angle position in the anterior maxilla', 'type': 'OTHER', 'description': 'After assessing the CBCT of patients, the immediate implants will be assessed if they were placed in the safe zone. the safe zone is described as; that there is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'state': 'Maadi', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed I Abou- El-Fettouh, MSc', 'role': 'CONTACT', 'email': 'ahmedkey7@hotmail.com'}, {'name': 'Nael A Mina, BDS', 'role': 'CONTACT'}], 'facility': 'International Dental Continuing Education', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '35855', 'city': 'Cairo', 'state': 'Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nesma M Shemais, PhD', 'role': 'CONTACT', 'email': 'nesma.shemais@dentistry.cu.edu.eg'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Nesma M Shemais, PhD', 'role': 'CONTACT', 'email': 'nesma.shemais@dentistry.cu.edu.eg', 'phone': '01005615697'}, {'name': 'Noha A Ghallab, PhD', 'role': 'CONTACT', 'email': 'noha.ghallab@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Noha A Ghallab, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Oral Medicine & Periodontology'}, {'name': 'Ahmed I Abou- El-Fettouh, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIU'}, {'name': 'Abdelrahman Zohny, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIU'}, {'name': 'Nael M Adel, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIU'}, {'name': 'Mariam S Abdelmalak, BDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MIU'}, {'name': 'Nesma M Shemais, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Oral Medicine & Periodontology, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in the department of Oral Medicine & Periodontology', 'investigatorFullName': 'Nesma Mohamed Fouad Shemais', 'investigatorAffiliation': 'Cairo University'}}}}