Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-27 @ 2:25 AM
Study NCT ID:
NCT04827693
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cortical Shield for Facial Bone Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016388', 'term': 'Tooth Loss'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D014082', 'term': 'Tooth Fractures'}, {'id': 'D018677', 'term': 'Tooth Injuries'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individuals presenting alveolar Facial Bone regeneration at re-entry', 'timeFrame': '1 year', 'description': 'Bone regeneration of the dent-alveolar socket'}], 'secondaryOutcomes': [{'measure': 'Pink Esthetic Scores', 'timeFrame': '1 year', 'description': 'Scores 1-10: the higher the score the better the esthetic outcome. Evaluates soft tissue esthetics around the regenerated bone \\& implant: mesial \\& distal papillae, curvature of facial mucosa, level of facial mucosa, root convexity/soft tissue color \\& texture'}, {'measure': 'Facial implant transparency', 'timeFrame': '1 year', 'description': 'Presence of implant transparency at 1 year follow-up: Yes/No'}, {'measure': 'Band of Keratinized tissue', 'timeFrame': '1 year', 'description': 'Evaluation of the presence of a band of keratinized tissue around the implant: \\> 2mm or \\< 2mm'}, {'measure': 'Implant crestal bone loss', 'timeFrame': '1 year', 'description': 'Radiographic evaluation of peri-implant marginal crestal bone loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tooth socket', 'bone grafting', 'bone regeneration', 'dental implant', 'osseointegration'], 'conditions': ['Tooth Loss', 'Tooth Diseases', 'Tooth Fracture', 'Tooth Injuries', 'Periodontal Bone Loss', 'Periodontitis', 'Peri-Implantitis', 'Tooth Decay']}, 'descriptionModule': {'briefSummary': 'To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.', 'detailedDescription': 'Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. Options of immediate or delay placement will be chosen based on the current status of the site to be restored at the time of referral.\n\nThe present cross-sectional quasi-experimental study is conducted in a specialty clinic in accordance to the requirements of the 1964 Helsinki Declaration', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA1 or ASA2 (American Society of Anesthesiologists)\n* Healthy individuals with good oral hygiene and motivation\n* No systemic uncontrolled diseases\n* Not taking drugs known to modify bone metabolism\n\nExclusion Criteria:\n\n* Individuals with untreated \\& generalized severe periodontitis\n* Heavy smokers (\\>10 cigarettes/day)\n* Poor oral hygiene\n* Diabetes (HbA1C \\>6.5% as cutoff value)\n* Uncontrolled cardiovascular disease\n* Poor overall health (ASA IV)'}, 'identificationModule': {'nctId': 'NCT04827693', 'briefTitle': 'The Cortical Shield for Facial Bone Reconstruction', 'organization': {'class': 'INDIV', 'fullName': 'Verdugo, Fernando, DDS'}, 'officialTitle': 'The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement', 'orgStudyIdInfo': {'id': 'Ver152007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immediate', 'description': 'implants are placed immediately after tooth extraction'}, {'label': 'Delayed', 'description': 'implants are placed months after the tooth has been extracted'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90077', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Fernando Verdugo, DDS, Corp', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Fernando Verdugo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sacro Cuore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verdugo, Fernando, DDS', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}