Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT05819632
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2023-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-15', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-04-15', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative pain', 'timeFrame': 'one week post operative', 'description': 'post -operative pain measured by visual analouge scale from 0 (no pain) to 10 (highest pain value)'}], 'secondaryOutcomes': [{'measure': 'Soft tissue healing of the palatal wound', 'timeFrame': 'up to three weeks post-operative', 'description': "Soft tissue healing of the palatal wound measured by Modified Landry's wound healing score from 1 indicates poorest healing to 5 indicates excellent healing"}, {'measure': 'Re-epithelization of the palatal wound', 'timeFrame': 'up to three weeks post-operative', 'description': 'Re-epithelization of the palatal wound using H2O2 test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palate; Wound']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systematically healthy patient (American Society of Anesthesiology class I and II).\n2. Male or female\n3. Patients with mucogingival defects scheduled for free gingival graft.\n4. Patients with good oral hygiene.\n\nExclusion Criteria:\n\n1. Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated.\n2. History of recent periodontal surgery at the donor site.\n3. Smokers.\n4. Pregnancy and lactation.\n5. Patients allergic to the used agents,\n6. Severe gagging reflex.\n7. Inability or unwillingness to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05819632', 'acronym': 'curcumin', 'briefTitle': 'Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Comparison of Topical Application of Curcumin Gel Versus Gelatin Sponge in Pain Management and Wound Healing After Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'CairoU28122022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curcumin gel', 'description': 'the denuded palatal area will be superficially covered with a continuous thin layer of curcumin gel 2% one time immediately after the surgery (curcumin gel will be prepared in 2% concentration on a carbapol base)according to (Bhatia et al., 2014)', 'interventionNames': ['Other: curcumin gel 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'gelatine sponge', 'description': 'absorbable gelatin sponge will be cut to the palatal wound size and applied. Following manual compression of the wound area, both agents will be secured in place using compressive palatal sling sutures.\n\ncommercial name (CUTANPLAST)', 'interventionNames': ['Other: curcumin gel 2%']}], 'interventions': [{'name': 'curcumin gel 2%', 'type': 'OTHER', 'description': 'curcumin gel 2%', 'armGroupLabels': ['curcumin gel', 'gelatine sponge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'state': 'Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed atef, phd', 'role': 'CONTACT', 'email': 'mohamed.atef@dentistry.ci.edu.eg', 'phone': '+201224302609'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Tansim k ABdelrahman, BDS', 'role': 'CONTACT', 'email': 'tansim.khaled@denistry.cu.edu.eg', 'phone': '+201001086940'}, {'name': 'mohamed atef, PHD', 'role': 'CONTACT', 'email': 'mohamed.atef@dentistry.cu.edu.eg', 'phone': '+201224302609'}], 'overallOfficials': [{'name': 'tansim k abdelrahman, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'master student'}, {'name': 'mohamed Atef, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecture of oral medicine and periodontology, faculty of dentistry ,Cairo university'}, {'name': 'manal m hosny, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of oral medicine and periodontology factuality of Dentistry,Cairo university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'masters degree candidate', 'investigatorFullName': 'Tansim Khaled Tawfik Abdelrahman', 'investigatorAffiliation': 'Cairo University'}}}}