Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT03018457
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Stability Quotient (ISQ)', 'timeFrame': '10 weeks', 'description': 'The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.'}], 'secondaryOutcomes': [{'measure': 'volume fraction of the bone', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'thickness between trabecular', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'Thickness of trabecular', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'trabecular separation', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'trabecular number', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'structural model index', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'trabecular pattern factor', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'connectivity density', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}, {'measure': 'degree of anisotropy', 'timeFrame': '10 weeks', 'description': 'Measured by Scanco microscanner'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trabecular microarchitecture', 'alveolar bone', 'osseointegration', 'dental implant'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.\n\nThis study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).\n\nThe cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.', 'detailedDescription': 'The aim of this study is to check whether the trabecular bone with its microarchitecture plays a predictive role in osseointegration of dental implants precisely in its biological stability phase or its secondary stability phase.\n\nIf this correlation is established, a larger study must be conducted to identify a profile of patients at risk for failure of osseointegration of the dental implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who need a dental implant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* affiliated patient or entitled to a social security scheme\n* requiring the installation of one or more dental implants\n* partial or total loss teeth, the height and width od the alveolar bone does not require bone grafting or guides regeneration\n\nExclusion Criteria:\n\n* patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary sinus, guided regeneration)\n* patient under corticosteroid therapy in the long term\n* patient who benefited from the head and neck radiotherapy\n* patient under bisphosphonates intravenously treatment\n* all cases immediate implantation and extraction of all implant put into immediate expenses'}, 'identificationModule': {'nctId': 'NCT03018457', 'briefTitle': 'Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.', 'orgStudyIdInfo': {'id': '1608111'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2016-A01680-51'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients who need a dental implants', 'interventionNames': ['Device: ISQ']}], 'interventions': [{'name': 'ISQ', 'type': 'DEVICE', 'description': 'Measured by Osstell.', 'armGroupLabels': ['patients who need a dental implants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Le Puy-en-Velay', 'country': 'France', 'facility': 'Cabinet dentaire MOLIMARD', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}], 'overallOfficials': [{'name': 'Thierry THOMAS, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}