Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT03164759
Status:
UNKNOWN
Last Update Posted:
2017-05-24
First Post:
2017-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone density', 'timeFrame': 'Baseline', 'description': 'Measuring bone density on CBCT by bluesky software representing by hounsfield unit pre operatively'}, {'measure': 'Implant stability', 'timeFrame': 'Immediate post operative', 'description': 'Post oprative measurements of implant stability by ostell device (ISQ)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implantation']}, 'descriptionModule': {'briefSummary': 'Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively', 'detailedDescription': 'Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving dental implants in healed non grafted sites in both arches', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients receiving dental implants in both arches\n* patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome\n* no intra-oral soft tissue defect that would render primary closure of the intra-oral wound\n\nExclusion Criteria:\n\n* patients with systemic diseases\n\n \\_ patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting\n* patients with sinus lifting done to place implants\n* immediate extraction sockets'}, 'identificationModule': {'nctId': 'NCT03164759', 'briefTitle': 'Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-05-23'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed B Mohammed, Master', 'role': 'CONTACT', 'email': 'Beso901@yahoo.com', 'phone': '00201223232606'}, {'name': 'Amr H El khadem, Phd', 'role': 'CONTACT', 'email': 'Amrelkhadem@gmail.com', 'phone': '01001162401'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Mohammed Basyoni Mohammed Abo El Azem', 'investigatorAffiliation': 'Cairo University'}}}}