Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-27 @ 7:38 PM
Study NCT ID:
NCT04980066
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004492', 'term': 'Edetic Acid'}], 'ancestors': [{'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-07-17', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation of root coverage', 'timeFrame': '6 months', 'description': 'the percentage of root coverage will be calculated in millimeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['i-PRF', 'EDTA'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Miller I/II isolated maxillary recession defects.\n* No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).\n* No occlusal interferences.\n* Full-mouth plaque index (PI) and gingival index (GI) scores of \\< 1.\n* Non-smokers.\n\nExclusion Criteria:\n\n* Pregnant patients\n* Presence of systemic disease or taking medication that interfere with periodontium'}, 'identificationModule': {'nctId': 'NCT04980066', 'briefTitle': 'Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'KD/10/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sticky bone and EDTA', 'description': 'treatment of gingival recession using sticky bone after root surface biomodification with EDTA', 'interventionNames': ['Procedure: Sticky bone and EDTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sticky bone', 'description': 'treatment of gingival recession using sticky bone', 'interventionNames': ['Procedure: Sticky bone']}], 'interventions': [{'name': 'Sticky bone and EDTA', 'type': 'PROCEDURE', 'description': 'treatment using Sticky bone after EDTA root surface biomodification', 'armGroupLabels': ['sticky bone and EDTA']}, {'name': 'Sticky bone', 'type': 'PROCEDURE', 'description': 'treatment using Sticky bone', 'armGroupLabels': ['Sticky bone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Dalia R Issa, PhD', 'role': 'CONTACT', 'email': 'dalia_rasheed@hotmail.com', 'phone': '01007753636', 'phoneExt': '002'}], 'facility': 'Faculty of Dentistry, Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Dalia R Issa, PhD', 'role': 'CONTACT', 'email': 'dalia_rasheed@hotmail.com', 'phone': '01007753636', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Dalia R Issa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal invistigator', 'investigatorFullName': 'Dalia Rasheed Issa', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}