Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04061694
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2019-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immediate Loading and Fully Guided Surgery: Single Implants
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': 'bjorn.gjelvold@gmail.com', 'phone': '+46709467870', 'title': 'Björn Gjelvold', 'organization': 'Folktandvården Skåne AB'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Serious events: loss of dental implant. Other adverse event: prosthetic restoration complications.', 'eventGroups': [{'id': 'EG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Dental implant loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Implant Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'OG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'MBL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'OG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Marginal bone loss MBL, measured in mm from implant abutment junction.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pink Esthetic Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'OG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.53', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '10.36', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'White Esthetic Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'OG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.79', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '7.76', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Oral Health Impact Profile - 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'OG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.10', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '16.48', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'FG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digital Immediate Loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing\n\nImmediate loading, fully guided surgery and 3D printed restoration: Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.'}, {'id': 'BG001', 'title': 'Immediate Loading', 'description': 'Immediate loading: Only subjected to immediate loading. Conventional procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '21.0', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '40.5', 'spread': '17.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-13', 'size': 175152, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-04T05:36', 'hasProtocol': True}, {'date': '2019-10-08', 'size': 148622, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-13T07:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2019-08-16', 'resultsFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-30', 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Implant Survival', 'timeFrame': '12 months', 'description': 'Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction'}, {'measure': 'MBL', 'timeFrame': '12 months', 'description': 'Marginal bone loss MBL, measured in mm from implant abutment junction.'}, {'measure': 'Pink Esthetic Score', 'timeFrame': '12 months', 'description': 'Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.'}, {'measure': 'White Esthetic Score', 'timeFrame': '12 months', 'description': 'White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.'}, {'measure': 'Oral Health Impact Profile - 14', 'timeFrame': '12 months', 'description': 'Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osseointegration Failure of Dental Implant']}, 'descriptionModule': {'briefSummary': 'To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age who had signed an informed consent\n* in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.\n\nExclusion Criteria:\n\n* general contraindications for oral surgery\n* patients with inadequate oral hygiene\n* need for bone grafting or ridge augmentation.'}, 'identificationModule': {'nctId': 'NCT04061694', 'briefTitle': 'Immediate Loading and Fully Guided Surgery: Single Implants', 'organization': {'class': 'OTHER', 'fullName': 'Folktandvården Skåne AB'}, 'officialTitle': 'Immediate Loading of Single Implants, Guided Surgery, Digital Impression and CAD/CAM Technology: Clinical and Patient-centered Outcome.', 'orgStudyIdInfo': {'id': 'DIL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Immediate loading', 'description': 'Single dental implant installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning and 3D printing', 'interventionNames': ['Procedure: Immediate loading, fully guided surgery and 3D printed restoration']}, {'type': 'OTHER', 'label': 'Immediate loading', 'description': 'Historic cohort subjected to immediate loading', 'interventionNames': ['Procedure: Immediate loading']}], 'interventions': [{'name': 'Immediate loading, fully guided surgery and 3D printed restoration', 'type': 'PROCEDURE', 'description': 'Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.', 'armGroupLabels': ['Digital Immediate loading']}, {'name': 'Immediate loading', 'type': 'PROCEDURE', 'description': 'Only subjected to immediate loading. Conventional procedure.', 'armGroupLabels': ['Immediate loading']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Centre of Dental Specialist Care', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Ann Wennerberg, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Folktandvården Skåne AB', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Oral Prosthodontics', 'investigatorFullName': 'Björn Gjelvold', 'investigatorAffiliation': 'Folktandvården Skåne AB'}}}}