Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT06755034
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OHIP-EDENT', 'timeFrame': 'From baseline to 5-year follow-up', 'description': 'Oral health-related quality of life questionnaire'}, {'measure': 'DSI', 'timeFrame': 'From baseline to 5-year follow-up', 'description': 'Denture Satisfaction Index (questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Preferred chewing side', 'timeFrame': 'From baseline to 5-year follow-up', 'description': 'Asymmetry Index'}, {'measure': 'Chewing efficiency', 'timeFrame': 'From baseline to 5-year follow-up', 'description': 'two-color mixing ability test'}, {'measure': 'Occlusal analysis', 'timeFrame': 'From baseline to 5-year follow-up', 'description': 'Dental Prescale System'}, {'measure': 'Plaque index', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'modified Plaque Index (modPI)'}, {'measure': 'Bleeding on probing', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'modified Bleeding Index (modBI)'}, {'measure': 'Pocket probing depth', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'Peri-implant probing depth'}, {'measure': 'Keratinized peri-implant tissues', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'Measurement of the keratinized tissue around implants'}, {'measure': 'Prosthodontic assessment', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'Number of prosthetic complications'}, {'measure': 'Peri-implant bone height', 'timeFrame': 'From implant loading to 5-year follow-up', 'description': 'Measured on radiographs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Completely Edentulous Patients']}, 'descriptionModule': {'briefSummary': 'The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed by the subject\n* Age ≥ 60 years\n* Edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth\n* Healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8))\n* Physical status ASA1 and ASA2\n\nExclusion Criteria:\n\n* Contraindications to the medical devices used, e.g. known hypersensitivity or allergy\n* Vulnerable subjects\n* Enrollment of the investigator, his/her family members, employees and other dependent persons\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to perform adequate oral hygiene\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, Parkinson etc. of the subject (Dementia: clock-drawing test score ≤ 5)\n* Surgical risk factors such as, but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication (ex. Bisphosphonates)\n* Heavy smoking habit: \\>20 cig/d\n* Reported severe bruxism or clenching habits, clinically present oro-facial pain\n* Depression: Geriatric Depression Scale \\> 9\n* Xerostomia: SSFR ≤ 0.7ml/min\n* Ridge dimensions \\<6 mm (width) by 10 mm (height) in the canine or midline area\n* Ridge defects requiring bone augmentation procedures'}, 'identificationModule': {'nctId': 'NCT06755034', 'acronym': 'c-SIMO', 'briefTitle': 'Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side Compared to the Midline Single-implant Overdenture Treatment Concept: an RCT With 5 Years of Follow-up', 'orgStudyIdInfo': {'id': 'DGPA_2024_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'c-SIMO', 'description': 'Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.', 'interventionNames': ['Device: c-SIMO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'm-SIMO', 'description': 'Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.', 'interventionNames': ['Device: m-SIMO']}], 'interventions': [{'name': 'c-SIMO', 'type': 'DEVICE', 'description': 'Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.', 'armGroupLabels': ['c-SIMO']}, {'name': 'm-SIMO', 'type': 'DEVICE', 'description': 'Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.', 'armGroupLabels': ['m-SIMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sabrina Maniewicz', 'role': 'CONTACT', 'email': 'sabrina.maniewicz@unige.ch', 'phone': '+41223794060'}, {'name': 'Sabrina Maniewicz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Clinics of Dental Medicine, University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Sabrina Maniewicz', 'role': 'CONTACT', 'email': 'sabrina.maniewicz@unige.ch', 'phone': '+4122 379 40 60'}], 'overallOfficials': [{'name': 'Sabrina Maniewicz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}, {'name': 'Frauke Müller', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frauke Müller', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Division', 'investigatorFullName': 'Frauke Müller', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}