Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-28 @ 1:30 AM
Study NCT ID:
NCT04769934
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2021-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Implant Insertion Torque on Peri-implant Bone Level.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'implant failure rate', 'timeFrame': '3 years', 'description': '% of implant failure'}, {'measure': 'patient satisfaction related to the implant treatment', 'timeFrame': '3 years', 'description': 'degree of satisfaction on factors such as function, comfort and esthetics through questionnaires'}, {'measure': 'prosthetic failure rate', 'timeFrame': '3 years', 'description': '% of prosthetic failure'}, {'measure': 'implant complications rate', 'timeFrame': '3 years', 'description': '% of implant complications'}, {'measure': 'prosthetic complications rate', 'timeFrame': '3 years', 'description': '% of prosthetic complications'}], 'primaryOutcomes': [{'measure': 'radiographic marginal bone level changes around the implant platform', 'timeFrame': '3 years', 'description': 'the changes (in mm) of the marginal bone level around the implant platform'}], 'secondaryOutcomes': [{'measure': 'Implant Stability Quotient (ISQ) changes', 'timeFrame': '3 years', 'description': 'the measurements will be performed with the instrument Penguin RFA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Implant Complication']}, 'descriptionModule': {'briefSummary': 'Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.', 'detailedDescription': 'The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.\n\nThe secondary outcomes would be:\n\n* To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA\n* To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates\n* The patient satisfaction related to the implant treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'partially edentulous patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All partially edentulous patients requiring simple Implant placement,\n* being at least 18-year-old and able to sign an informed consent,\n* The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).\n\nExclusion Criteria:\n\n* Heavy smokers (more than 10 cigarettes/day).\n* Immunosuppressed or immunocompromised patients\n* Uncontrolled diabetes\n* Active periodontal disease\n* Patients with a full mouth marginal bleeding score higher than 20%\n* Addiction to alcohol or drugs\n* Psychiatric problems\n* Severe caries, periapical lesions, acute infection (abscess)\n* Immediate post-extractive implants (at least 2 months after extraction have to elapse)\n* Patients unable to commit to 3-year follow-up.\n* Patients treated or under treatment with intravenous amino- bisphosphonates.\n* Patients participating to other studies, if the present protocol could not be fully adhered to.'}, 'identificationModule': {'nctId': 'NCT04769934', 'briefTitle': 'Impact of Implant Insertion Torque on Peri-implant Bone Level.', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Impact of Implant Insertion Torque on Peri-implant Bone Level.', 'orgStudyIdInfo': {'id': '2018-00666'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Penguin RFA', 'type': 'DEVICE', 'description': 'to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Irena Sailer, Prof. Dr.', 'role': 'CONTACT', 'email': 'irena.sailer@unige.ch', 'phone': '+41 22 3794050'}], 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Irena Sailer, Prof. Dr.', 'role': 'CONTACT', 'email': 'irena.sailer@unige.ch', 'phone': '+41 22 3794050'}], 'overallOfficials': [{'name': 'Irena Sailer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Irena Sailer, Head of the Division', 'investigatorFullName': 'Irena Sailer', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}