Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:47 AM
Study NCT ID:
NCT07345520
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VCMX, PRF and SCTG Treatment in the Gingival Recessions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Parallel-Group, Randomized, Controlled Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Complete Root Coverage', 'timeFrame': '12 Months', 'description': 'Percentage of CRC will be calculated as: (number of teeth achieving complete root coverage) ÷ (total treated teeth)\\] × 100'}], 'secondaryOutcomes': [{'measure': 'Percentage of Mean Root Coverage', 'timeFrame': '12 months', 'description': 'Percentage of root coverage will be calculated as: Percentage of root coverage: \\[(preoperative recession depth - postoperative recession depth) ÷ preoperative recession depth\\] × 100'}, {'measure': 'Recession depth', 'timeFrame': '12 month', 'description': 'RD will be measured from the cemento-enamel junction (CEJ) to the gingival margin and reported in millimeters (mm).'}, {'measure': 'Probing depth', 'timeFrame': '12 months', 'description': 'Probing depth will be measured from the gingival margin to the base of the sulcus and reported in millimeters (mm).'}, {'measure': 'Clinical attachment level', 'timeFrame': '12 months', 'description': 'Clinical attachment level will be measured from the cemento-enamel junction to the sulcus base and reported in millimeters (mm).'}, {'measure': 'Keratinized gingiva width', 'timeFrame': '12 months', 'description': 'KGW will be measured from the mucogingival junction to the gingival margin and reported in millimeters (mm).'}, {'measure': 'Gingival Thickness', 'timeFrame': '12 months', 'description': 'Gingival thickness (GT) will beevaluated at the mid-facial aspect, 2 mm apical to the gingival margin in the attached gingiva or alveolar mucosa, using a #15 endodontic spreader (Bahadır Diş, Istanbul, Turkey) with a rubber stopper under local anesthesia and reported in milimeters.'}, {'measure': 'Postoperative Pain assessed using a Visual Analog Scale (VAS)', 'timeFrame': 'From the day of surgery through postoperative day 10 (11 days)', 'description': 'Postoperative pain will be assessed using a visual analog scale (VAS). Patients were asked to record the highest perceived pain each day from the day of surgery through the 10th postoperative day (total of 11 days).'}, {'measure': 'Dentin Hypersensitivity Score assessed using Air Stimulus (HSS)', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'Dentin hypersensitivity will be assessed using a 1-second air stimulus applied to the buccal surface of the treated tooth. Patients rated the perceived hypersensitivity on a numerical rating scale ranging from 0 (no hypersensitivity) to 10 (unbearable hypersensitivity).'}, {'measure': 'Pink Esthetic Score (PES) self-assessment', 'timeFrame': 'Baseline, 6 months, and 12 months', 'description': 'Esthetic outcomes will be evaluated using the Pink Esthetic Score (PES). Patients self-assessed gingival contour, gingival color, and overall esthetic appearance using a numerical rating scale ranging from 0 (unpleasant) to 10 (excellent).'}, {'measure': 'Postoperative Analgesic Consumption', 'timeFrame': 'From the day of surgery through postoperative day 10 (11 days)', 'description': 'Postoperative analgesic consumption will be assessed by recording the total number of analgesic tablets taken by patients from the day of surgery through the 10th postoperative day.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Localized']}, 'descriptionModule': {'briefSummary': 'Comparison of Volume-Stable Collagen Matrix, Platelet-Rich Fibrin, and Subepithelial Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions: A Parallel-Group, Randomized, Controlled Clinical Trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria were as follows:\n\n1. ≥2 mm buccal recessions affecting ≥2 adjacent maxillary teeth;\n2. systemically and periodontally healthy;\n3. non-smokers;\n4. Miller Class I-II (no interproximal attachment or CEJ loss);\n5. probing depth (PD) \\<3 mm;\n6. GT ≥1 mm;\n7. KGW ≥2 mm;\n8. identifiable CEJ;\n9. full-mouth plaque index (PI) \\<20%(O'Leary et al., 1972) and gingival index (GI) score of 0(Löe, 1967) and\n10. vital teeth to be treated.\n\nExclusion criteria included:\n\n1. smokers;\n2. caries/restorations/abrasions in the treated area, furcation involvement;\n3. contraindications to surgery;\n4. pregnancy or lactation;\n5. medications compromising healing;\n6. surgery in the same region within 2 years;\n7. bleeding disorders;\n8. requirement for antibiotic prophylaxis; and\n9. collagen allergy."}, 'identificationModule': {'nctId': 'NCT07345520', 'briefTitle': 'VCMX, PRF and SCTG Treatment in the Gingival Recessions', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'Comparison of Volume Stable Collagen Matrix, Platelet-Rich Fibrin and Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: A Randomized, Parallel Group, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '21.12.2022/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volume Stable Collagen Matrix+Coronally Advanced Flap', 'description': 'The pre-prepared Volume Stable Collagen Matrix will be moistened with saline solution (SF) and placed beneath a coronally positioned flap at the recipient site during periodontal surgery.', 'interventionNames': ['Biological: Volume-Stable Collagen Matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet-Rich Fibrin+Coronally Advanced Flap', 'description': "Autologous platelet-rich fibrin (PRF) will be prepared from the patient's venous blood according to a standardized protocol and placed beneath a coronally advanced flap at the recipient site during periodontal surgery to enhance soft tissue healing and regeneration.", 'interventionNames': ['Biological: Volume-Stable Collagen Matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subepithelial Connective Tissue Graft+Coronally Advanced Flap', 'description': "A subepithelial connective tissue graft harvested from the patient's palate and placed beneath a coronally positioned flap at the recipient site during periodontal surgery.", 'interventionNames': ['Biological: Volume-Stable Collagen Matrix']}], 'interventions': [{'name': 'Volume-Stable Collagen Matrix', 'type': 'BIOLOGICAL', 'description': 'Volume-Stable Collagen Matrix', 'armGroupLabels': ['Platelet-Rich Fibrin+Coronally Advanced Flap', 'Subepithelial Connective Tissue Graft+Coronally Advanced Flap', 'Volume Stable Collagen Matrix+Coronally Advanced Flap']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yıldırım Beyazit University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Seyma Bozkurt Doğan', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}