Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT05284461
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2022-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone to implant contact', 'timeFrame': '3 months after healing', 'description': 'It is a Percentage estimation of native bone in direct contact to implant determined by histological assessments (optical microscopy)'}, {'measure': 'Peri-implant inflammation of the soft tissues', 'timeFrame': '3 months after healing', 'description': 'Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.'}, {'measure': 'Density of the peri-implant soft tissues', 'timeFrame': '3 months after healing', 'description': 'Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous; Alveolar Process, Atrophy']}, 'descriptionModule': {'briefSummary': 'The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders\n\nExclusion Criteria:\n\n* evidence of systemic or psychic pathology that contraindicates implant treatment.'}, 'identificationModule': {'nctId': 'NCT05284461', 'briefTitle': 'Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .', 'orgStudyIdInfo': {'id': 'USAL_2021_JMONT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Mechanized parallel abutments', 'description': 'Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard', 'interventionNames': ['Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)']}, {'type': 'EXPERIMENTAL', 'label': 'Anodized parallel abutments', 'description': 'Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard', 'interventionNames': ['Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)']}, {'type': 'EXPERIMENTAL', 'label': 'Mechanized convergent abutments', 'description': 'Implants were immediately covered with this kind of abutments after insertion. Only the geometry of the emergence profile varies with regards to the gold standard', 'interventionNames': ['Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)']}, {'type': 'EXPERIMENTAL', 'label': 'Anodized convergent abutments', 'description': 'Implants were immediately covered with this kind of abutments after insertion. Both the surface treatment and the geometry vary with regards to the gold standard', 'interventionNames': ['Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)']}], 'interventions': [{'name': 'dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)', 'type': 'DEVICE', 'description': 'Dental implants with transepithelial abutments with distinct morphology', 'armGroupLabels': ['Anodized convergent abutments', 'Anodized parallel abutments', 'Mechanized convergent abutments', 'Mechanized parallel abutments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Clinica Odontológica de la Universidad de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Prosthodontics', 'investigatorFullName': 'JAVIER MONTERO', 'investigatorAffiliation': 'University of Salamanca'}}}}