Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 12:42 PM
Study NCT ID:
NCT01644058
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immediate Loading Of Dental Implants: A Pilot Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elham.emami@umontreal.ca', 'phone': '514-343-6111', 'title': 'Elham Emami, DDS, MSc, PhD', 'phoneExt': '6053', 'organization': 'Université de Montréal'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Phase-I clinical trial with small sample size and a pre-post design with no control group.'}}, 'adverseEventsModule': {'timeFrame': 'All participants were assessed for adverse events. "0" participants were found to have serious or non-serious events after observation.', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Satisfaction With the Immediate Loading Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants'}], 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '34.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '99'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': "Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Oral-health-related Quality of Life With the Immediate Loading Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants\n\nImmediate loading'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Calling patients on the waiting list of the undergraduate implant clinic of the Université de Montréal and referrals from active study subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '7.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigators were not involved in data analysis'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2012-07-16', 'resultsFirstSubmitDate': '2013-08-26', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction With the Immediate Loading Protocol', 'timeFrame': '4 months', 'description': "Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively)."}, {'measure': 'Oral-health-related Quality of Life With the Immediate Loading Protocol', 'timeFrame': '4 months', 'description': 'Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['immediate-loading', 'patient-based outcomes'], 'conditions': ['Dental Implantation']}, 'descriptionModule': {'briefSummary': 'Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.', 'detailedDescription': 'In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimal age of 18 years\n* Complete edentulism for more than 1 year\n* Wear of total conventional prosthesis for more than 1 year\n* Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).\n\nExclusion Criteria:\n\n* Any absolute or relative contra-indication to implant therapy\n* Physical incapacity to render oral or prosthetic hygiene\n* Incapacity to obtain a free and informed consent\n* Incapacity to assist to planned follow up appointments\n* Incapacity to understand and complete questionnaires\n\nExclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:\n\n* Inadequate bone quality: IT\\<35 Ncm\n* Inadequate primary stability: ISQ\\<60'}, 'identificationModule': {'nctId': 'NCT01644058', 'briefTitle': 'Immediate Loading Of Dental Implants: A Pilot Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success', 'orgStudyIdInfo': {'id': 'UDEM-EE-2012b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate loading', 'description': 'Immediate loading of 2 endo-osseous mandibular implants', 'interventionNames': ['Procedure: Immediate loading']}], 'interventions': [{'name': 'Immediate loading', 'type': 'PROCEDURE', 'otherNames': ['Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture'], 'armGroupLabels': ['Immediate loading']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3Y1P2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Elham Emami, DDS, MSc,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal, Faculty of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'D.D.S., M. Sc., Ph. D, Professor', 'investigatorFullName': 'Elham Emami', 'investigatorAffiliation': 'Université de Montréal'}}}}