Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04744012
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Periostal Pocket Flap Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of bone augmentation', 'timeFrame': '4 months', 'description': 'Volume of bone augmentation of the surgical sites was measured in the postoperative parasagittal CT scans using a region of interest (ROI) containing the entire bone box regenerated area using the closed polygon tool of the OsiriX software'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periostal Pocket Flap Technique', 'PPFT'], 'conditions': ['Bone Regeneration']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to propose a modification of the original periostal pocket flap technique consisting in replacing the xenograft by a conglomerate which contains autologous bone obtained from the future implant site through biological drilling technique and PRGF (Plasma Rich in Growth Factors)', 'detailedDescription': 'Materials and methods: 8 patients referred for implant placement and with a slight bucco-lingual (BL) width deficiency in alveolar bone were included in the study. Patients were placed dental implants and bone width was augmented by using the conglomerate mentioned above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients included in this case series were collected from Clinica Dental Alcalá, were operated on by the same surgeon and fullfilled the inclusion and exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a favorable bone density and favorable bone length but insufficient bone width that could compromise implant placement\n\nExclusion Criteria:\n\n* Smokers (\\>10 cigarettes per day) and patients with severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)'}, 'identificationModule': {'nctId': 'NCT04744012', 'briefTitle': 'Modified Periostal Pocket Flap Technique', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Modified Periostal Pocket Flap Technique: a Case Series', 'orgStudyIdInfo': {'id': 'P-15/568'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unique group', 'description': "After local anesthesia, a full thickness flap was elevated from the lingual wall and a partial thickness flap was performed in the buccal one. After that, the buccal periosteum was detached and dental implants were placed following the biological drilling protocol, getting autologous bone particles from the implant site.\n\nPatient's blood collection was performed and the plasm obtained was poured down on a sterile container and mixed with autologous bone particles collected previously during the drilling procedure. Finally the graft was placed in the pocket prepared previously and the surgical wound was sutured in two planes.", 'interventionNames': ['Procedure: Modified Periostal Pocket Flap Technique']}], 'interventions': [{'name': 'Modified Periostal Pocket Flap Technique', 'type': 'PROCEDURE', 'description': "After local anesthesia, a full thickness flap was elevated from the lingual wall and a partial thickness flap was performed in the buccal one. After that, the buccal periosteum was detached and dental implants were placed following the biological drilling protocol, getting autologous bone particles from the implant site.\n\nPatient's blood collection was performed and the plasm obtained was poured down on a sterile container and mixed with autologous bone particles collected previously during the drilling procedure. Finally the graft was placed in the pocket prepared previously and the surgical wound was sutured in two planes.", 'armGroupLabels': ['unique group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jesús Torres, Associate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jesús Torres García Denche', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}