Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-04 @ 12:51 PM
Study NCT ID:
NCT04532359
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement', 'timeFrame': 'At 3 months after implant placement', 'description': 'Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability', 'timeFrame': 'At 3 months after implant placement', 'description': 'Correlation between the type of bone (maxilla / mandible and fibula) and implant stability'}, {'measure': 'Evaluation of the correlation between the irradiation dose received at the implant site and implant stability', 'timeFrame': 'At 3 months after implant placement', 'description': 'Correlation between the irradiation dose received at the implant site and implant stability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper aero-digestive tract Cancer', 'Dental implant placement'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective is to describe the evolution of implant stability between the date of implant placement and 3 months later when the implant is implementated in patients treated for cancer of the upper aero-digestive tract', 'detailedDescription': 'Oral implantology is widely used during prosthetic rehabilitation in healthy patients but also in patients presenting cancers of the upper aero-digestive tract.\n\nSystems for measuring implant stability using resonance frequency analysis exist and are used clinically by some practitioners, such as the Ostell® system from W\\&H. These systems make it possible to determine the osseointegration of the implant, and thus the appropriate time to insert the implant, by comparing the value obtained with average values.\n\nImplant survival rates are lower for implants placed in irradiated bone, with an implant stability quotient value identical to implant placement but lower after osseointegration. Only one study shows implant stability quotient values\\> 60 with a success rate of 100% at 41 months on implants placed in patients having received radiotherapy. However, no clinical study has investigated the kinetics of osseointegration and the stability of implants placed on a microanastomosis fibula flap as part of aesthetic and prosthetic reconstruction after cancer of the upper aero-digestive tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx) who are going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx\n* Patient having been treated by external radiotherapy and/or having benefited from a microanastomosis fibula flap\n* Patient going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap\n* Non-opposition to the study\n\nExclusion Criteria:\n\n* Patient having difficulties speaking and understanding French\n* Patient under tutorship or curatorship'}, 'identificationModule': {'nctId': 'NCT04532359', 'acronym': 'STABICAN', 'briefTitle': 'Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'STABICAN : Measurement of Implant Stability by Analysis of the Resonance Frequency in Patients Treated for Cancer of the Upper Aero-digestive Tract', 'orgStudyIdInfo': {'id': 'STABICAN - ET20-099'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implant placement', 'type': 'DEVICE', 'description': 'Implant placement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Gaëlle CHAUX-BODARD, MD', 'role': 'CONTACT', 'email': 'anne-gaelle.bodard@lyon.unicancer.fr', 'phone': '+33 4.78.78.29.59'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Ellen BLANC', 'role': 'CONTACT', 'email': 'ellen.blanc@lyon.unicancer.fr', 'phone': '+33 4.78.78.2967'}, {'name': 'Anne-Gaëlle CHAUX-BODARD, MD', 'role': 'CONTACT', 'email': 'anne-gaelle.bodard@lyon.unicancer.fr', 'phone': '+33 4.78.78.29.59'}], 'overallOfficials': [{'name': 'Anne-Gaëlle CHAUX-BODARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}