Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05750004
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2023-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deviation Between Virtual and Actual Computer Guided Immediate Implants Using the New Safe Angle Position Concept
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-19', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angular deviations', 'timeFrame': '9 months', 'description': 'Angular discrepancy (measured in degrees) be-tween the planned and actual implant position respective to the center of the implant body. It is primarily ascribed to a variation in point of implant entry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implant placement', 'computer guided', 'safe angle position', 'Angular deviation'], 'conditions': ['Immediate Implants']}, 'descriptionModule': {'briefSummary': 'The goal of this case series study is to assess the degree of angular deviation between virtual and actual computer guided immediate implant placement in anterior maxilla using the new safe angle position concept and the resultant effects on soft and hard tissues. Patients with non-restorable anterior maxillary teeth will be managed with flapless computer guided immediate implant placement fabricated using safe angle concept.', 'detailedDescription': "Various research investigated the distance deviations at the entrance and apical points of angular deviation to investigate the clinical accuracy of implant placement using these surgical procedures. Additionally, the 3D variations between the intended and postoperative implant placements are evaluated in the mesio-distal, bucco-lingual, and vertical directions. The vertical orientations are all constrained by bone volume; nevertheless, the greatest contributors to 3D deviations in implant location are bucco-lingual and mesio-distal deviations. Few research have been done to examine the variables affecting implant placement accuracy using free-hand surgical procedures. Due to drilling errors caused by drills travelling along the paths of least resistance during IIP and socket morphology, implants frequently end up in the facial region even when surgical guidelines are present. This is more typical for anterior maxilla implants. The incisal long axis, which is perpendicular to the palate or the occlusal plane, and the root's long axis connect at an angle. The incisal plane line will be at the cingulum position or slightly palatal to it when this relation is shifted more palatally, and this position is known as the safe angle position. According to the amount of palatal bone present, the occlusion with the opposing dentition, and the type of restoration, the more palatal relocation to the cingulum is carried out. Immediate implants in the safe angle position are more likely to predictably achieve good implant location (less angular deviation), improved aesthetics and emergence profile, and less stresses on the implant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 20 years to 50 years of both genders and in good general health.\n2. Maxillary anterior tooth that cannot be retained due to non-periodontitis, including fracture, endodontic failure, and root resorption, bounded by natural teeth.\n3. Intact buccal bone plate (via CBCT).\n4. The extraction socket has at least 3-5 mm apical bone.\n\nExclusion Criteria:\n\n* 1\\. Smokers 2. Pregnant and lactating females: Pregnancy as this will limit recording the outcome data eg: CBCT.\n\n 3\\. Medically compromised patients, as uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31) 4. Patients with active infection related at the site of implant/bone graft placement.\n\n 5\\. Patients with untreated active periodontal diseases. 6. Patients with parafunctional habits. 7. Refuse to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05750004', 'briefTitle': 'Deviation Between Virtual and Actual Computer Guided Immediate Implants Using the New Safe Angle Position Concept', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'Deviation Between Virtual and Actual Computer Guided Immediate Implant Placement in Anterior Maxilla Using the New Safe Angle Position Concept and Resultant Effects on Soft and Hard Tissues (A Case Series Study)', 'orgStudyIdInfo': {'id': 'OSA3231001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computer guided immediate implant placement', 'description': 'Atraumatic extraction followed by immediate implant placement using safe angle position computer guided surgical stents.', 'interventionNames': ['Procedure: computer guided immediate implant placement']}], 'interventions': [{'name': 'computer guided immediate implant placement', 'type': 'PROCEDURE', 'description': 'Atraumatic extraction followed by immediate implant placement using safe angle position computer guided surgical stents, followed by customized healing abutments. after 3 months, Impressions for final prosthesis will be done', 'armGroupLabels': ['Computer guided immediate implant placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'International Dental Contining Education Centre (IDCE)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Abo El Futtouh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical director of implant speciality program', 'investigatorFullName': 'Ahmed Abo El Futtouh', 'investigatorAffiliation': 'Misr International University'}}}}