Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 2:45 AM
Study NCT ID:
NCT03225495
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success', 'timeFrame': '12 months', 'description': 'According to criteria described by Albrektsson et al. 1986'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implant', 'Narrow Implant', 'Implant Fracture', 'Guided Bone Regeneration']}, 'descriptionModule': {'briefSummary': 'The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. To do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. Cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One missing teeth in position: upper central incisor, canine or premolar\n* alveolar ridge thickness of 6 - 8 mm\n* alveolar ridge height of ≥ 10 mm\n\nExclusion Criteria:\n\n* Missing data\n* ASA ≥ III'}, 'identificationModule': {'nctId': 'NCT03225495', 'briefTitle': 'Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'Éxito a Corto Plazo de Los Implantes Ultra-estrechos (2,75 mm) en comparación Con Implantes de Plataforma Regular (4,3 mm) Que Requieren regeneración ósea Vestibular simultánea. Ensayo clínico Aleatorizado', 'orgStudyIdInfo': {'id': '39/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Implant', 'interventionNames': ['Procedure: Standard implant']}, {'type': 'EXPERIMENTAL', 'label': 'Ultra-narrow Implant', 'interventionNames': ['Procedure: Ultra-narrow implant']}], 'interventions': [{'name': 'Standard implant', 'type': 'PROCEDURE', 'description': 'Arm - Standard Implant: implant placement in combination with guided bone regeneration;', 'armGroupLabels': ['Standard Implant']}, {'name': 'Ultra-narrow implant', 'type': 'PROCEDURE', 'description': 'Arm - Ultra-narrow implant: implant placement without guided bone regeneration', 'armGroupLabels': ['Ultra-narrow Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rui Figueiredo, Phd', 'role': 'CONTACT', 'email': 'ruipbfigueiredo@gmail.com', 'phone': '00 34 93 402 42 74'}], 'facility': 'Hospital Odontològic - Universitat de Barcelona', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Rui Figueiredo, PhD', 'role': 'CONTACT', 'email': 'ruipbfigueiredo@gmail.com', 'phone': '00 34 93 402 42 74'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Adin Implants', 'class': 'UNKNOWN'}, {'name': 'Geistlich Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD - Assitant Professor', 'investigatorFullName': 'Rui Figueiredo', 'investigatorAffiliation': 'University of Barcelona'}}}}