Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06357351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment
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': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the recession width in millimeter', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'self-report assessment by using the UNC-15 Periodontal Probe, measured at the level of Cemento-Enamel Junction CEJ.'}, {'measure': 'Measuring the recession depth in millimeter', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction CEJ to the free gingival junction.'}, {'measure': 'Measuring the width of keratinized gingiva in millimeter', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'self-report assessment by using the UNC-15 Periodontal Probe. measured from the free gingiva margin to the mucogingival junction.'}, {'measure': 'Mean of root coverage', 'timeFrame': 'baseline, and 6 months', 'description': 'was measured by the following formula:. Mean root coverage formula: (pre-operative recession depth - post-operative recession depth)/(pre-operative recession depth ) ×100'}], 'secondaryOutcomes': [{'measure': 'Measuring the probing depth', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'self-report assessment by using the UNC-15 Periodontal Probe. Measured from the free gingival margin to the base of the sulcus.'}, {'measure': 'Measuring the plaque index', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'According to Silness and Leo, this index determines the thickness of the plaque along the gingival margin. possible score range from 0 (no plaque) to 1 ( thin plaque located at gingival margin only detected by periodontal probe), 2 ( moderate plaque thickness detected by naked eye located at gingival margin), and 3 ( abundant plaque thickness at gingival margin and interproximal area)'}, {'measure': 'Measuring the gingival index', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'According to Silness and Leo, this index determines the description of the gingiva of examined teeth. possible score range from 0 (normal gingiva) to 1 (mild inflammation; slight erythema; no bleeding.) / 2 (moderate inflammation; erythema and bleeding on probing) or 3 (severe inflammation; severe erythema, swelling, and spontaneous bleeding).'}, {'measure': 'Clinical attachment level', 'timeFrame': 'baseline, 3 months and 6 months', 'description': 'self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction to the base of the pocket.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'referencesModule': {'references': [{'pmid': '39806320', 'type': 'DERIVED', 'citation': 'Abdelhaleem M, Saleh W, Elmeadawy S. Treatment of gingival recession with vestibular incision subperiosteal tunnel access and advanced platelet-rich fibrin. BMC Oral Health. 2025 Jan 14;25(1):63. doi: 10.1186/s12903-024-05398-w.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.\n* Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of \\<3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤1.\n* Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions\n\nExclusion Criteria:\n\n* the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.\n* Allergies to medicaments used in the treatment process.\n* Patients with removable or fixed dentures.\n* Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.\n* Participants with smoking, tobacco chewing, and alcohol consumption.\n* The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.'}, 'identificationModule': {'nctId': 'NCT06357351', 'briefTitle': 'Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects', 'orgStudyIdInfo': {'id': 'VISTA in gingival recession'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VISTA technique and collagen membrane', 'description': 'Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane.', 'interventionNames': ['Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.']}, {'type': 'EXPERIMENTAL', 'label': 'VISTA technique and advanced platelet rich fibrin', 'description': 'Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF).', 'interventionNames': ['Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.']}], 'interventions': [{'name': 'vestibular incision sub periosteal tunnel access ( VISTA) technique.', 'type': 'PROCEDURE', 'description': 'In comparison between the two groups, the first group uses collagen membrane and the other group uses advanced PRF using the same surgical technique (VISTA)', 'armGroupLabels': ['VISTA technique and advanced platelet rich fibrin', 'VISTA technique and collagen membrane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master candidate', 'investigatorFullName': 'Marwa Abdelfattah Elkhamisy', 'investigatorAffiliation': 'Mansoura University'}}}}