Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-04 @ 3:01 PM
Study NCT ID:
NCT01505335
Status:
UNKNOWN
Last Update Posted:
2012-01-06
First Post:
2012-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-05-26', 'releaseDate': '2015-05-10'}], 'estimatedResultsFirstSubmitDate': '2015-05-10'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['alveolar nerve, inferior', 'ultrasound', 'digital radiography, dental', 'nerve injury'], 'conditions': ['Comparison Between Ultrasound and Clinical Measurements']}, 'descriptionModule': {'briefSummary': 'The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed on computerized tomography images.', 'detailedDescription': 'To date, the most accurate method to assess the distance from the alveolar crest to the IAC is cone beam computerized tomography (CBCT). This technique carries with it some potential concerns, including measurements errors, inability to perform intra-operative radiographs substantial financial and radiation costs.\n\nIn the present study patients will have a CBCT of the mandible taken. Sites where implants will be inserted will be marked on the CBCT, measurements of the distance from bone crest to the roof of the inferior alveolar canal (BC-IAC) will be performed.\n\nDuring implant surgery the depth of the osteotomy (OD) will be measured using a periodontal probe; OD and the distance from the bottom of the osteotomy to the roof of the IAC (residual distance - RD) will be measured using a standard JetGuide® device. In addition, standard panoramic radiographs will be taken with a surgical gauge in the osteotomy which will enable us to measure the RD radiographically.\n\nThe correlation between the radiographic and clinical BC-IAC distance will be the primary outcome variable. The same correlation for the RD between the Jetguide readings and the linear measurements on the panoramic radiographs will serve as the secondary outcome variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects attentding the clinic, requiring dental implant therapy in the posterior part of the lower jaw.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* missing teeth in the premolar and molar areas of the lower jaw\n\nExclusion Criteria:\n\n* pregnancy\n* pacemakers'}, 'identificationModule': {'nctId': 'NCT01505335', 'briefTitle': 'The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)', 'orgStudyIdInfo': {'id': '0460-11-RMB CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implant osteotomy measurements', 'description': 'Drilled implant locations', 'interventionNames': ['Device: US depth measurements']}], 'interventions': [{'name': 'US depth measurements', 'type': 'DEVICE', 'otherNames': ['Jetguide', 'Ultrasonic measurement device'], 'description': 'Measurement of the distance between the apex of the drilled implant site and the IAC', 'armGroupLabels': ['Implant osteotomy measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus, Dept. of Periodontology', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Prof. Eli Machtei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-05-10', 'type': 'RELEASE'}, {'date': '2015-05-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rambam Health Care Campus'}}}}