Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT01928004
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mandibular Implants in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2013-08-20', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Denture satisfaction', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'VAS-scale score to evaluate the subjective satisfaction with the denture'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in OHRQoL', 'timeFrame': 'at 3, 12, 24 adn 36 months', 'description': 'OHIP-Edent questionnaire, 20 questions'}, {'measure': 'Change from Baseline in cognitive function', 'timeFrame': 'at 12, 24 and 36 months', 'description': 'Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test'}, {'measure': 'Change from Baseline in Independence', 'timeFrame': 'at 12, 24 and 36 months', 'description': 'IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence'}, {'measure': 'Change from Baseline in MNA', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'Mini-nutritional Assessement questionnaire (Guigoz 1994)'}, {'measure': 'Change from Baseline in Blood markers', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)'}, {'measure': 'Change from Baseline in BMI', 'timeFrame': 'at 12, 24 and 36 months', 'description': 'Body Mass Index kg/m2'}, {'measure': 'Change from Insertion in implant survival', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'inserted implants in vivo'}, {'measure': 'Change from Insertion in Pocket depth', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'mesial and distal peri-implant probing depth'}, {'measure': 'Change from Insertion in Plaque index', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'Plaque index on implants (Silness \\& Loe 1963) Denture plaque index'}, {'measure': 'Change from Insertion in peri-implant bone loss', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs'}, {'measure': 'Change from Baseline in Chewing efficiency', 'timeFrame': 'at Intervention, 3, 12, 24 and 36 months', 'description': 'two color mixing test with bi-colored chewing gum (Schimmel et al 2007)'}, {'measure': 'Change from Baseline in Maximum bite force', 'timeFrame': 'at Intervention, 3, 12, 24 and 36 months', 'description': 'unilateral maximal bite force measured with force gauge'}, {'measure': 'Change from Baseline in Stimulated Saliva Flow Rate', 'timeFrame': 'at Intervention, 3, 12, 24 and 36 months', 'description': 'whole saliva collected after chewing wax for 2 minutes on one side'}, {'measure': 'Changes from Baseline in Masseter Muscle Thickness', 'timeFrame': 'at 3, 12, 24 and 36 months', 'description': 'ultrasound measurements of the masseter muscle thickness in contracted and relaxed state'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['edentulous', 'complete denture'], 'conditions': ['Edentulous Complete Denture Wearers']}, 'referencesModule': {'references': [{'pmid': '24158342', 'type': 'RESULT', 'citation': 'Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.'}, {'pmid': '30500094', 'type': 'RESULT', 'citation': 'Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 75 years or older\n* living institutionalized or receiving help for the ADL\n* edentulous\n* wearing complete dentures\n* the lower denture had to cause discomfort to the degree that the patients were seeking treatment\n\nExclusion Criteria:\n\n* severe clinical depression\n* dementia\n* poorly controlled diabetes\n* immunosuppression\n* treatment with bisphosphonates\n* condition precluding the surgical intervention for implant placement'}, 'identificationModule': {'nctId': 'NCT01928004', 'briefTitle': 'Mandibular Implants in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Geneva, Switzerland'}, 'officialTitle': 'Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MDGPA_02'}, 'secondaryIdInfos': [{'id': 'ITI_458_2006', 'type': 'OTHER_GRANT', 'domain': 'International Team of Implantology ITI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'implant placement', 'description': 'insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture', 'interventionNames': ['Device: Implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'denture reline', 'description': 'conventional reline of mandibular complete denture', 'interventionNames': ['Procedure: Conventional reline']}], 'interventions': [{'name': 'Implant placement', 'type': 'DEVICE', 'otherNames': ['Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter)', 'Locator® attachments (Zest Anchors: Escondido, CA, USA)'], 'description': 'Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.', 'armGroupLabels': ['implant placement']}, {'name': 'Conventional reline', 'type': 'PROCEDURE', 'description': 'conventional reline of the existing mandibular complete denture', 'armGroupLabels': ['denture reline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Frauke Müller, Prof. Dr. med. dent.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair', 'investigatorFullName': 'Frauke Müller', 'investigatorAffiliation': 'University of Geneva, Switzerland'}}}}