Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04543292
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2020-09-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Integrity of screw head', 'timeFrame': '6 weeks', 'description': 'Integrity of the screw head observed in photographs'}, {'measure': 'Integrity of screw head', 'timeFrame': '6 weeks', 'description': 'Retightening after screw after unscrew'}], 'secondaryOutcomes': [{'measure': 'Occurrence of prosthetic complications', 'timeFrame': '6 weeks', 'description': 'Occurrence of prosthetic complications during follow-up'}, {'measure': 'Occurrence of biological complications', 'timeFrame': '6 weeks', 'description': 'Occurrence of biological complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': 'Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Clinical need for the placement of a implant-supported dental prosthesis\n* Clinical need for the filling of the prosthetic chimney\n* Signing informed consent\n\nExclusion Criteria:\n\n* Inability of follow-up'}, 'identificationModule': {'nctId': 'NCT04543292', 'briefTitle': 'Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Eduardo Anitua'}, 'officialTitle': 'Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.', 'orgStudyIdInfo': {'id': 'BTI_01_EP/20/MATFILL'}, 'secondaryIdInfos': [{'id': 'Exp. 812/20/EC', 'type': 'OTHER', 'domain': 'AEMPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MATFILL', 'description': 'Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head.', 'interventionNames': ['Device: MATFILL (PTFE)']}], 'interventions': [{'name': 'MATFILL (PTFE)', 'type': 'DEVICE', 'description': 'Filling of the prosthetic chimney with the compressed material', 'armGroupLabels': ['MATFILL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01005', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Eduardo Anitua Private Clinic', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Eduardo Anitua, MD, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eduardo Anitua Private Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Eduardo Anitua', 'class': 'OTHER'}, 'collaborators': [{'name': 'BTI Biotechnology Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}