Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-29 @ 8:31 PM
Study NCT ID:
NCT04292132
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057893', 'term': 'Immediate Dental Implant Loading'}], 'ancestors': [{'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Implant stability', 'timeFrame': '0,3,6,12,24,36 months', 'description': 'Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration'}, {'measure': 'Change of Implant stability', 'timeFrame': '0,3,6,12,24,36 months', 'description': 'Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentistry', 'Mandibular Atrophy', 'Mandibular Overdenture'], 'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.', 'detailedDescription': "Hypothesis:\n\nEspecially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure.\n\nResearch Question:\n\nHow safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time?\n\nMaterials and methods\n\nEnrollment:\n\n* 20 patients without relevant pre-existing conditions, from the age of 60 years\n* edentulous mandible, alveolar ridge atrophy\n\nStatistical Analysis:\n\nWhen planning the study, it is estimated that bone resorption in the peri-implant area of the immediate-care implants is greater than in the late-treated implants. 10 patients per group are required with a t-test (α = 0.05) and a power of 80% if the null hypothesis is formulated as follows: -difference of means is 0 and the alternative - expected difference of means is 1mm, common standard deviation is 0.75.\n\nCollective A (open healing - immediate loading): Insertion of a new, prefabricated total mandibular prosthesis on the day of the operation immediately postoperatively after screwing in the Locator® abutments.\n\nPolymerization of the corresponding Locator® matrices in the newly incorporated lower jaw denture in the patient's mouth.\n\nCollective B (closed implant healing - conventional loading): 3 months after implantation Exposure of the primary closed implants. Immediately following insertion of the prefabricated full-thickness UK prosthesis and retention by the implants using Locator® abutments.\n\nTest parameters:\n\n1. Intraoperative torque measurement in Ncm\n2. Radiological measurement of periimplant bone height using orthopantomogram\n3. 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant.\n4. Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe.\n5. Analysis of implant stability using the Periotest® and Osstell® measuring instruments according to a standardized scheme: The strength values are performed in a measuring range consisting of a straight line through the center of the implant and the resulting 180 ° circle sector anterior to this line results. After multiple measurements (5-fold) the lowest numerical value for the Periotest® and for the RFA (Osstell®) the lowest value documented."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 or older\n* edentulous lower jaw with advanced atrophy\n* poor fit and retention even with a new prosthesis\n\nExclusion Criteria:\n\n* poor general condition (ASA classification grade IV or more), or\n* high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)'}, 'identificationModule': {'nctId': 'NCT04292132', 'briefTitle': 'Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung', 'orgStudyIdInfo': {'id': 'MUGraz Neoss1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional loading', 'description': 'Loading of 4 interforaminal implants three months after surgery.', 'interventionNames': ['Procedure: Implant placement', 'Procedure: conventional loading']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Loading', 'description': 'Loading of 4 interforaminal implants immediately after surgery.', 'interventionNames': ['Procedure: Implant placement', 'Procedure: immediate loading']}], 'interventions': [{'name': 'Implant placement', 'type': 'PROCEDURE', 'description': 'interforaminal placement of 2 implants', 'armGroupLabels': ['Conventional loading', 'Immediate Loading']}, {'name': 'immediate loading', 'type': 'PROCEDURE', 'description': 'immediate loading with a locator retained mandibular overdenture', 'armGroupLabels': ['Immediate Loading']}, {'name': 'conventional loading', 'type': 'PROCEDURE', 'description': 'conventional loading with a locator retained mandibular overdenture 3 months postoperatively', 'armGroupLabels': ['Conventional loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8051', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Stephan Acham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neoss Ltd., Harrogate, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}