Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05389059
Status:
UNKNOWN
Last Update Posted:
2022-05-24
First Post:
2022-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-04-24', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in gingival recession depth on the buccal sides of type one gingival recessionRT1', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'The primary outcome of the study is the reduction in gingival recession depth on the buccal sides of RT1 gingival recession, between the baseline preoperative measurement and follow-up at 3 months and 6 months. The Recession Depth (RD) is Measured in millimeter (mm) from CEJ (Cemento-Enamel-Junction) to the gingival margin using UNC-15 probe.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Gingival Thickness (GT)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Gingival Thickness (GT) is determined at 1.5 mm apical to the gingival margin using a caliper (endodontic reamer#20) rounded to the nearest 0.1mm.'}, {'measure': 'Improvement in the Keratinized Tissue Height (KTH)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Keratinized Tissue Height (KTH) is measured in millimeters (mm) taken at the mid buccal aspect of the involved teeth from the gingival margin to the muco-gingival junction, by a manual periodontal probe (UNC-15 probe,Hu-Friedy,Chicago,USA).'}, {'measure': 'Reduction in the Recession Width (RW)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Recession Width (RW) is measured in millimeter (mm) at the Cement-Enamel Junction (CEJ) using UNC-15 probe.'}, {'measure': 'Reduction in Probing Pocket Depth (PPD)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Probing Pocket Depth (PPD) is measured in millimeter (mm) from the gingival margin to the apical extend of the probe.'}, {'measure': 'Reduction Clinical Attachment Level (CAL)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Clinical Attachment Level (CAL) is measured in millimeter (mm) from the CEJ to the apical extend of the probe.'}, {'measure': 'Measuring Plaque-Index (PI)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Plaque-Index (PI) is measured as a percentage of the presence of Plaque on four surfaces of the teeth using a manual periodontal probe.'}, {'measure': 'Measuring Bleeding On Probing (BOP)', 'timeFrame': 'Between the baseline preoperative measurement and follow-up at 3 months and 6 months', 'description': 'Bleeding On Probing (BOP) is measured as a percentage of sites with bleeding on probing using a manual periodontal probe.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Recession', 'Collagen Matrix', 'Plasma rich proten'], 'conditions': ['Gingival Diseases', 'Traumatic Injury']}, 'descriptionModule': {'briefSummary': 'This study is proposing the use of i-PRF clot as a scaffold for the XCM in order to obtain a novel biomaterial, incorporating active growth factors and collagen matrix in a single framework, based on the potential effect of i-PRF to enhance fibroblast activity and angiogenesis stimulation for treatment of multiple gingival recession.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least two localized gingival recessions on either sides of the maxilla and/or mandible excluding molar region.\n* The cemento-enamel junction (CEJ) is visible in the teeth for root coverage procedures.\n* All recessions are type 1recession RT1 (cairo et al,2011) which correspond to Miller I\\&II gingival recession\n* All patients must demonstrate adequate plaque control with a fullmouth plaque score less than 20% and with .\n* All patients at least 18 years of age and of both genders.\n\nExclusion Criteria:\n\n* Smoker Patients .\n* Patients with diabetes.\n* Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.\n* pregnant or nursing women.\n* Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).\n* Patients with a disease affecting connective tissue metabolism.\n* Patients allergic to collagen.'}, 'identificationModule': {'nctId': 'NCT05389059', 'briefTitle': 'Injectable Platelet Rich Fibrin With Collagen Matrix in Treatment of Multiple Gingival Recession.', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'The Value of Injectable Platelet Rich Fibrin With Volume Stable Collagen Matrix in Treatment of Multiple Gingival Recession; a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '519622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control arm', 'description': 'Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\\&II gingival recession.', 'interventionNames': ['Procedure: CAF+CM']}, {'type': 'OTHER', 'label': 'Experimental arm', 'description': 'Patients with Gingival recessions are type 1 recession RT1 (cairo et al,2011) which correspond to Miller I\\&II gingival recession.', 'interventionNames': ['Procedure: CAF+CM', 'Procedure: I-PRF']}], 'interventions': [{'name': 'CAF+CM', 'type': 'PROCEDURE', 'description': 'Periodontal surgery including CAF+CM application', 'armGroupLabels': ['Control arm', 'Experimental arm']}, {'name': 'I-PRF', 'type': 'PROCEDURE', 'description': 'Periodontal surgery including CAF+CM application with i-PRF', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10047', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'University of Baghdad / College of Dentistry', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Basima Gh Ali, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Baghdad'}, {'name': 'Thair AL Hassan, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Baghdad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD student', 'investigatorFullName': 'Basima Ghaffoori Ali', 'investigatorAffiliation': 'University of Baghdad'}}}}