Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT04753866
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562489', 'term': 'Lymphoid Interstitial Pneumonia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lip Support Changes in 3D (μm)', 'timeFrame': '1 month', 'description': 'Quantitatively measure 3D facial alterations induced by full arch implant rehabilitation (in Root Mean Square)'}], 'secondaryOutcomes': [{'measure': 'Facial Alterations in 2D (mm)', 'timeFrame': '1 month', 'description': 'Evaluate facial modifications caused by full arch implant rehabilitation by measuring distances between pre-determined facial landmarks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Esthetics', 'Dental Implants', 'Three-Dimensional Imaging', 'Oral Surgery'], 'conditions': ['Lip', 'Prosthesis User', 'Soft Tissue']}, 'descriptionModule': {'briefSummary': 'Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.', 'detailedDescription': "As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for full arch implant rehabilitation\n\nExclusion Criteria:\n\n* Presence of facial hair, braces, make up, earrings or any facial deformity'}, 'identificationModule': {'nctId': 'NCT04753866', 'briefTitle': 'Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations', 'organization': {'class': 'OTHER', 'fullName': 'Implantology Institute'}, 'officialTitle': 'Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations', 'orgStudyIdInfo': {'id': 'II2020-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitated', 'description': 'Initial lip support condition of the patient when presents himself/herself at the office with indication for full arch implant rehabilitation. Then, the patient is facially scanned before and after the implant surgery.', 'interventionNames': ['Device: Facial scanner']}], 'interventions': [{'name': 'Facial scanner', 'type': 'DEVICE', 'description': 'The Bellus3D facial scanner will be used to scan the patient before and after implant rehabilitation in order to produce .obj files that allow 3D comparisons and to obtain discrepancy values regarding lip support.', 'armGroupLabels': ['Rehabilitated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070-064', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto de Implantologia', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'João Caramês, DDS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Implantology Institute'}, {'name': 'Duarte Marques, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Implantology Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Implantology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}