Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT04780360
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2019-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2019-11-17', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Wound Healing', 'timeFrame': '1 week', 'description': 'Measured By Modified Early Wound Healing Index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing']}, 'descriptionModule': {'briefSummary': 'Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or augmentation the dimensions of gingival tissue. The procedure require harvesting tissue from a the palate, which increases the complexity of the procedure and patient discomfort. Complications after harvesting a graft would be pain, inflammation, bleeding, flap necrosis and infection in the donor site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mucogingival defects scheduled for sub epithelial connective tissue graft\n* Age at least 18 years.\n* Not having any systemic disease that could compromise wound healing\n* No periodontal surgery on the experimental sites.\n* No smoking,\n* No pregnancy or lactation\n\nExclusion Criteria:\n\n* Patients with coagulation disorders\n* patients on corticosteroids, with uncontrolled diabetes, or with any systemic disease that precluded periodontal surgery\n* patients with a history of contact dermatitis to formaldehyde\n* Loss of maxillary premolars and molars\n* Medications or antibiotics used in the previous 6 months\n* Pregnancy or lactation\n* Smoking'}, 'identificationModule': {'nctId': 'NCT04780360', 'briefTitle': 'Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue Graft', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Post Operative Pain, Early Wound Healing, and the Time of Application of Cyanoacrylates Tissue Adhesives Versus Silk Sutures at the Palatal Donor Area of Subepithelial Connective Tissue Grafts (CTG) A Randomized Clinical Trial: Comparative Study', 'orgStudyIdInfo': {'id': '567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cayanoacrylate tissue adhesives', 'description': 'thin layers of high viscosity blend of n-butyl and 2-octyl cayanoacrylate tissue adhesive will be applied and rinsed with saline at least three times with interval of at least 30 seconds', 'interventionNames': ['Procedure: Cayanoacrylate tissue adhesives']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silk suture material', 'description': 'interrupted knots', 'interventionNames': ['Procedure: Silk suture']}], 'interventions': [{'name': 'Cayanoacrylate tissue adhesives', 'type': 'PROCEDURE', 'description': 'Cyanoacrylates are a family of strong fast-acting adhesives with industrial, medical, and household uses. They are various esters of cyanoacrylic acid. The acryl groups in the resin rapidly polymerize in the presence of water to form long, strong chains', 'armGroupLabels': ['Cayanoacrylate tissue adhesives']}, {'name': 'Silk suture', 'type': 'PROCEDURE', 'description': 'Non Absorbalble suture materiel used to fixed the edges of the incision in place until healing', 'armGroupLabels': ['Silk suture material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan Ahmed, Adminstrator', 'role': 'CONTACT', 'email': 'hassan.ahmed@dentistry.cu.edu.eg', 'phone': '23634965', 'phoneExt': '02'}], 'facility': 'Faculty of Dentistry, Cairo Universty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed S Mohamed Ibrahium Abdullah, Invistegator', 'role': 'CONTACT', 'email': 'dr.mohamed15.ms@gmail.com', 'phone': '01283626196', 'phoneExt': '02'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Mohamed Saeed Mohamed Ibrahuim Abdullah', 'investigatorAffiliation': 'Cairo University'}}}}