Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-04 @ 3:18 AM
Study NCT ID:
NCT05407493
Status:
UNKNOWN
Last Update Posted:
2022-06-07
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009957', 'term': 'Oroantral Fistula'}], 'ancestors': [{'id': 'D016155', 'term': 'Oral Fistula'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Closure success', 'timeFrame': 'One month after surgery', 'description': 'Measured with probing and Valsalva test'}], 'secondaryOutcomes': [{'measure': 'Patient reported Pain', 'timeFrame': 'Each week for one month', 'description': 'Pain on a VAS scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oroantral Fistula']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients with a clinical diagnosis of oroantral fistula among those referring to the Dental department of Siena University Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .\n\nExclusion Criteria:\n\ni) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.'}, 'identificationModule': {'nctId': 'NCT05407493', 'briefTitle': 'Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication', 'orgStudyIdInfo': {'id': 'ODO002, 26/06/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Buccal flap', 'description': 'The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures.'}, {'label': 'Double-layer', 'description': 'A combination between a buccal trapezoidal flap and a palatal connective pedicle flap.'}, {'label': 'Buccal flap with L-PRF', 'description': 'A L-PRF plug is interposed between the fistula and the buccal sliding flap.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Baldini', 'role': 'CONTACT', 'email': 'baldini.nicola@gmail.com', 'phone': '3382809460'}], 'facility': 'Dipartimento di Odontostomatologia', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'Nicola Baldini', 'role': 'CONTACT', 'email': 'baldini.nicola@gmail.com', 'phone': '00393382809460'}], 'overallOfficials': [{'name': 'Nicola Discepoli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Siena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}