Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 6:15 PM
Study NCT ID:
NCT06621433
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2024-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-28', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-28', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'up to 6 months', 'description': 'The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.'}, {'measure': 'Clinical attachment loss', 'timeFrame': 'up to 6 months', 'description': 'Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe'}, {'measure': 'Recession width (RW)', 'timeFrame': 'up to 6 months', 'description': 'Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe'}, {'measure': 'Recession height (RH)', 'timeFrame': 'up to 6 months', 'description': "It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe"}, {'measure': 'Width of keratinized gingiva (KT)', 'timeFrame': 'up to 6 months', 'description': 'Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gingival recession type 2 according to Cairo et al (2011).\n* Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).\n* Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)\n* Clinically thick gingival biotype (1mm \\< gingival thickness).\n* Anterior esthetic zone.\n\nExclusion Criteria:\n\n* Patients with gingival recession types 1 and 3 according to Cairo et al.\n* Inadequate amount of attached gingiva (AG \\< 2 mm).\n* Uncooperative patients.\n* Smoking more than 10 cigarettes per day.\n* Patients with known systemic conditions or taking medications that may affect soft tissue healing.\n* Pregnant and lactating women.\n* Patients with parafunctional habits."}, 'identificationModule': {'nctId': 'NCT06621433', 'briefTitle': 'Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1/1-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronally advanced flap (CAF) in conjunction with titanium prepared PRF', 'interventionNames': ['Other: T-PRF with CAF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAF in conjunction with subepithelial connective tissue graft (SECTG)', 'interventionNames': ['Other: SECTG with CAF']}], 'interventions': [{'name': 'T-PRF with CAF', 'type': 'OTHER', 'description': 'Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.', 'armGroupLabels': ['Coronally advanced flap (CAF) in conjunction with titanium prepared PRF']}, {'name': 'SECTG with CAF', 'type': 'OTHER', 'description': 'Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.', 'armGroupLabels': ['CAF in conjunction with subepithelial connective tissue graft (SECTG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rizk Beshir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc. candidate of periodontology', 'investigatorFullName': 'Rizk Beshir', 'investigatorAffiliation': 'Alexandria University'}}}}