Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT07196566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-29
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-Layer Closure Technique Using Buccal and Palatal Flaps for Oroantral Fistula
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All enrolled patients will undergo closure of chronic oroantral fistula using double-layer technique consist of split thickness buccal, palatal flap and rotational palatal underlaying connective tissue.\n\nthis a single-arm, prospective clinical study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence of fistula', 'timeFrame': 'one week -4 weeks', 'description': 'presence of oroantral fistula or not'}, {'measure': 'vestibular height', 'timeFrame': '1-3 months postoperatively', 'description': 'using periodontal prob'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oroantral fistula', 'double layer closure', 'buccal flap', 'palatal flap', 'rotational palatal connective tissue flap'], 'conditions': ['Oroantral Fistula', 'Double Layer']}, 'descriptionModule': {'briefSummary': 'A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.', 'detailedDescription': 'The proposed double-layer technique achieved high success rates in closing oroantral fistulas with minimal postoperative complications, reduced facial edema, and better preservation of vestibular depth compared to conventional techniques.\n\nA prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.\n\nThis technique demonstrated reliable, tension-free closure with excellent clinical outcomes, reduced postoperative facial edema, and preserved vestibular depth, supporting its potential as an effective and safe surgical option for managing oroantral fistulas.\n\nThe purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with oroantral fistula\n\nExclusion Criteria:\n\n* patients with repeated oroantral fistula closure'}, 'identificationModule': {'nctId': 'NCT07196566', 'acronym': 'OAF-DLC', 'briefTitle': 'Double-Layer Closure Technique Using Buccal and Palatal Flaps for Oroantral Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Double-Layer Closure of Oroantral Fistula Using Buccal Split-Thickness and Palatal Subepithelial Connective Tissue Flaps', 'orgStudyIdInfo': {'id': 'TantaOMS-OAF-DLC2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap', 'description': 'A prospective clinical case series was conducted involving twelve patients with oroantral fistulas ≥5 mm in diameter. Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.', 'interventionNames': ['Procedure: Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft']}], 'interventions': [{'name': 'Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft', 'type': 'PROCEDURE', 'description': 'Closure was performed using split-thickness buccal and palatal mucosal flaps with a subepithelial palatal connective tissue graft rotated to cove the bony defect and sutured to the buccal periosteum as the first layer, then the buccal mucosa sutured with the palatal one . Clinical evaluations were conducted at regular intervals over a 3-month postoperative period, assessing wound healing, fistula recurrence, pain, facial edema, infection, and donor site morbidity.', 'armGroupLabels': ['Double-Layer Closure of Oroantral Fistula Using Buccal and palatal Split-Thickness flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'faculty of dentistry, Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'mohamed s abdelhameed, Asst lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant in oral and maxillofacial department, faculty pf dentistry, Tanta university', 'investigatorFullName': 'Mohamed sobhie abdelhameed', 'investigatorAffiliation': 'Tanta University'}}}}