Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT04632693
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ginigval thickness', 'timeFrame': '6 months', 'description': 'Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.'}], 'secondaryOutcomes': [{'measure': 'Root Coverage Esthetic Score', 'timeFrame': '6 months', 'description': 'A system proposed for evaluating esthetic outcomes of root coverage procedures. The RES system evaluated five variables at 6-months after surgery: the level of the gingival margin, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color.'}, {'measure': 'Early Healing Index', 'timeFrame': '6 months', 'description': 'A system proposed for the clinical assessment of the early wound events by using a differentiated early wound healing index (EHI) (Wachtel et al., 2003).'}, {'measure': 'Gingival Recession Depth (RD)', 'timeFrame': '6 months', 'description': 'Measured from the CEJ to the most apical extension of the gingival margin.'}, {'measure': 'Gingival Recession Width (RW)', 'timeFrame': '6 months', 'description': 'Measured horizontally between the borders of the recession at the level of CEJ.'}, {'measure': 'Percentage of root coverage', 'timeFrame': '6 months', 'description': '(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.'}, {'measure': 'Probing Depth (PD)', 'timeFrame': '6 months', 'description': 'Measured from the gingival margin to the bottom of the gingival sulcus.'}, {'measure': 'Clinical Attachment Level (CAL)', 'timeFrame': '6 months', 'description': 'Measured from the CEJ to the bottom of the gingival sulcus.'}, {'measure': 'Height of Keratinized Tissue (KTH)', 'timeFrame': '6 months', 'description': 'Measured as the distance between the gingival margin and the mucogingival junction (MGJ).\n\nAll measurements will be performed by means of the UNC periodontal probe and will be rounded up to the nearest millimeter.'}, {'measure': 'Post-Operative Pain', 'timeFrame': '2 weeks', 'description': "Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively."}, {'measure': 'Post-Surgical Patient Satisfaction', 'timeFrame': '6 months', 'description': 'A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Thickness']}, 'descriptionModule': {'briefSummary': 'Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.', 'detailedDescription': 'Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients 18 years or older.\n2. Periodontally and systemically healthy.\n3. Buccal recession defects classified as Cairo RT1.\n4. Presence of identifiable CEJ (Zucchelli et al., 2010).\n5. Clinical indication and/or patient request for recession coverage.\n6. O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).\n\nExclusion Criteria:\n\n1. Cairo RT2 or RT3 recession defects.\n2. Pregnant females.\n3. Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).\n4. Handicapped and mentally retarded patients.\n5. Patients undergoing radiotherapy.\n6. Teeth with cervical restorations, abrasion and malalignment.\n7. Presence of systemic disease that would affect wound healing."}, 'identificationModule': {'nctId': 'NCT04632693', 'briefTitle': 'Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession', 'orgStudyIdInfo': {'id': '3-6-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAF with SCTG and vitamin C', 'description': 'Coronally advanced flap with subepithelial connective tissue graft and vitamin C.', 'interventionNames': ['Procedure: CAF with SCTG and Vitamin C injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAF with SCTG', 'description': 'Coronally advanced flap with subepithelial connective tissue graft.', 'interventionNames': ['Procedure: CAF with SCTG alone']}], 'interventions': [{'name': 'CAF with SCTG and Vitamin C injection', 'type': 'PROCEDURE', 'description': 'Injection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession.', 'armGroupLabels': ['CAF with SCTG and vitamin C']}, {'name': 'CAF with SCTG alone', 'type': 'PROCEDURE', 'description': 'Coronally advanced flap with subepithelial connective tissue graft.', 'armGroupLabels': ['CAF with SCTG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Andrew Albert A. Zaki, MSc', 'role': 'CONTACT', 'email': 'andrew.anwar@dentistry.cu.edu.eg', 'phone': '01274805636'}], 'facility': 'Faculty of Oral and Dental Medicine - CU', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Andrew Albert A. Zaki, MSc', 'role': 'CONTACT', 'email': 'andrew.anwar@dentistry.cu.edu.eg', 'phone': '01274805636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrew Albert Anwar Zaki', 'investigatorAffiliation': 'Cairo University'}}}}