Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 7:37 AM
Study NCT ID:
NCT01961635
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2013-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-29', 'studyFirstSubmitDate': '2013-10-06', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival Inflammatory Changes from baseline to 12 weeks', 'timeFrame': 'Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks', 'description': 'measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic'}], 'secondaryOutcomes': [{'measure': 'Marginal Bone Loss', 'timeFrame': 'measured at 12 weeks post-implant installation', 'description': 'Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic'}, {'measure': 'Gingival height', 'timeFrame': '12 weeks post-implant installation', 'description': 'measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic'}, {'measure': 'Osseointegration', 'timeFrame': '12 weeks post-implant installation', 'description': 'compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments'}, {'measure': 'Height from gingiva to abutment', 'timeFrame': '12 weeks post implant installation', 'description': 'height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dental Implants', 'Zirconia Abutments', 'Titanium abutments', 'Acrylic abutments', 'Gingival Healing', 'Inflammation', 'Bone loss'], 'conditions': ['Bone Loss', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?', 'detailedDescription': 'Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single unit implant rehabilitation\n* Maxilla and mandible\n* Must accept treatment plan\n* Must sign informed consent\n* dental extraction performed at least 3 month prior\n* Must have at least 6 mm of residual bone\n* Absence of oral lesions\n* keratinized tissue must be present\n\nExclusion Criteria:\n\n* If smoking and/or other drug addiction is present\n* If local anesthetic allergy is present\n* Patient subjected to chemical or radiotherapy\n* if Hepatic disease is present\n* If immunodepression is present\n* If Pregnancy is present\n* If Diabetes is present\n* If Heart disease is present'}, 'identificationModule': {'nctId': 'NCT01961635', 'briefTitle': 'Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss', 'organization': {'class': 'OTHER', 'fullName': 'Implantology Institute'}, 'officialTitle': 'Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'II-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zirconia Abutments', 'description': 'Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2', 'interventionNames': ['Device: dental implants', 'Device: Zirconia abutments', 'Procedure: Subcrestal', 'Device: platform-switch', 'Procedure: one-time one-abutment', 'Procedure: Torque 20 n/cm2']}, {'type': 'EXPERIMENTAL', 'label': 'Titanium Abutments', 'description': 'Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2', 'interventionNames': ['Device: dental implants', 'Device: Titanium Abutments', 'Procedure: Subcrestal', 'Device: platform-switch', 'Procedure: one-time one-abutment', 'Procedure: Torque 20 n/cm2']}, {'type': 'EXPERIMENTAL', 'label': 'Cad-Cam Acrylic abutments', 'description': 'Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2', 'interventionNames': ['Device: dental implants', 'Device: cad-cam acrylic abutments', 'Procedure: Subcrestal', 'Device: platform-switch', 'Procedure: one-time one-abutment', 'Procedure: Torque 20 n/cm2']}], 'interventions': [{'name': 'dental implants', 'type': 'DEVICE', 'otherNames': ['T3 - Biomet 3I Implants', 'Platform-Switch 4.1', 'Abutment Diameter 3.25'], 'description': 'place implant according fabricant guidelines, 2mm sub-crestally', 'armGroupLabels': ['Cad-Cam Acrylic abutments', 'Titanium Abutments', 'Zirconia Abutments']}, {'name': 'Zirconia abutments', 'type': 'DEVICE', 'otherNames': ['Zirconia cad-cam abutment', '3.25 Abutment connection'], 'description': 'place zirconia abutment on the day of implant placement', 'armGroupLabels': ['Zirconia Abutments']}, {'name': 'Titanium Abutments', 'type': 'DEVICE', 'otherNames': ['Titanium Encode - biomet 3I Implants', '3,25 abutment connection'], 'description': 'place titanium abutment on the day of implant placement', 'armGroupLabels': ['Titanium Abutments']}, {'name': 'cad-cam acrylic abutments', 'type': 'DEVICE', 'otherNames': ['Cad-cam acrylic abutment', '3.25 platform'], 'description': 'place cad-cam acrylic abutment on the day of implant placement', 'armGroupLabels': ['Cad-Cam Acrylic abutments']}, {'name': 'Subcrestal', 'type': 'PROCEDURE', 'description': 'place implant 2mm below crestal bone', 'armGroupLabels': ['Cad-Cam Acrylic abutments', 'Titanium Abutments', 'Zirconia Abutments']}, {'name': 'platform-switch', 'type': 'DEVICE', 'description': 'abutment platform is narrow than implant diameter', 'armGroupLabels': ['Cad-Cam Acrylic abutments', 'Titanium Abutments', 'Zirconia Abutments']}, {'name': 'one-time one-abutment', 'type': 'PROCEDURE', 'otherNames': ['one time abutment', 'final abutment on the day of surgery'], 'description': 'place the final abutment on the day of surgery and not remove it', 'armGroupLabels': ['Cad-Cam Acrylic abutments', 'Titanium Abutments', 'Zirconia Abutments']}, {'name': 'Torque 20 n/cm2', 'type': 'PROCEDURE', 'otherNames': ['manual torque'], 'description': 'the amount of torque applied to the abutment', 'armGroupLabels': ['Cad-Cam Acrylic abutments', 'Titanium Abutments', 'Zirconia Abutments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1500-662', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Faculdade de Medicina Dentária de Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'João Caramês, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Medicina Dentária de Lisboa'}, {'name': 'André Chen Chen, Msc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculdade de Medicina Dentária de Lisboa'}, {'name': 'Elena Cervino, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Implantology Institute'}, {'name': 'Helena Francisco, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculdade de Medicina Dentária de Lisboa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Implantology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc', 'investigatorFullName': 'Andre Chen', 'investigatorAffiliation': 'Implantology Institute'}}}}