Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-28 @ 12:41 AM
Study NCT ID:
NCT05814003
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain (VAS scale)', 'timeFrame': 'first day postoperative to 30 days (days)', 'description': 'VAS scale from 0 no pain to 10 excruciating pain (healing)'}], 'secondaryOutcomes': [{'measure': 'Number of analgesic and anti inflammatory pills consumed', 'timeFrame': 'first day postoperative to 30 days (days)', 'description': 'Minimizing the pain and inflammation during healing process post operative swelling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Infections', 'Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '30794264', 'type': 'BACKGROUND', 'citation': 'Paolantonio M, De Ninis P, Secondi L, Femminella B. The Full-Thickness Palatal Graft Technique: Description of an Original Surgical Technique and 15 Case Reports. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):267-277. doi: 10.11607/prd.3741.'}, {'pmid': '24640997', 'type': 'BACKGROUND', 'citation': 'Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.'}, {'pmid': '30152618', 'type': 'BACKGROUND', 'citation': 'Wyrebek B, Gorski B, Gorska R. Patient morbidity at the palatal donor site depending on gingival graft dimension. Dent Med Probl. 2018 Apr-Jun;55(2):153-159. doi: 10.17219/dmp/91406.'}, {'pmid': '32559041', 'type': 'BACKGROUND', 'citation': 'Tseng ES, Tavelli L, Wang HL. Palatal Pedicle Flaps for Soft Tissue Augmentation. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):581-588. doi: 10.11607/prd.4561.'}]}, 'descriptionModule': {'briefSummary': 'Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .', 'detailedDescription': 'After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders\n\nExclusion Criteria:\n\n* smokers insufficient palatal donor sits un realistic expectations'}, 'identificationModule': {'nctId': 'NCT05814003', 'acronym': 'RCT', 'briefTitle': 'Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Clinical Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Graft Donor Sites', 'orgStudyIdInfo': {'id': 'HW37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hydroxylate flavones', 'description': 'flavonoids mainly derived from citrus peel and have numerous strong biological activities, including anti-inflammatory , antioxidant , antimicrobial , and anticancer', 'interventionNames': ['Drug: hydroxylate flavones solid dispersion application', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'alveogyl', 'description': 'ALVOGYL is a brown fibrous paste which contains per 100 g the following active ingredients : 25.70 g of butamben, 15.80 g of iodoform and 13.70 g of eugenol.', 'interventionNames': ['Drug: hydroxylate flavones solid dispersion application', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'stent', 'description': 'acrylic resin material used to cover denuded soft tissues', 'interventionNames': ['Drug: hydroxylate flavones solid dispersion application']}], 'interventions': [{'name': 'hydroxylate flavones solid dispersion application', 'type': 'DRUG', 'otherNames': ['Natural therapy without side effects'], 'description': 'this drug has the antibacterial and anti inflammatory actions could help the palatal donor sites to promote the wound healing', 'armGroupLabels': ['alveogyl', 'hydroxylate flavones', 'stent']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Dough inert material without any therapeutic action', 'armGroupLabels': ['alveogyl', 'hydroxylate flavones']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'ahmed fikry', 'role': 'CONTACT', 'email': 'mortadafikry@hotmail.com', 'phone': '01005432223', 'phoneExt': '002'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed Mortada, professor', 'role': 'CONTACT', 'email': 'mortadafikry@hotmail.com', 'phone': '20 0100 543 2223'}], 'overallOfficials': [{'name': 'Ahmed Mortada, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor - faculty of dentistry', 'investigatorFullName': 'Ahmed Mortada', 'investigatorAffiliation': 'Assiut University'}}}}