Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 12:28 PM
Study NCT ID:
NCT04800250
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Case-control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-12', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean root coverage obtained with both techniques', 'timeFrame': '6 months', 'description': 'To compare the mean root coverage obtained with the Creos® Mucogain matrix and connective tissue graft in the treatment of Cairo RT1 class maxillary recessions (Miller Class 1).'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain with both techniques', 'timeFrame': '6 months', 'description': 'To compare postoperative pain with both techniques'}, {'measure': 'Postoperative complications with both techniques', 'timeFrame': '10 days', 'description': 'To compare the occurrence of postoperative complications (haemorrhage, edema) within the first 10 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions)\n* Patient non-smoker\n* Patient affiliated to social security\n* Patient signed informed consent.\n\nExclusion criteria:\n\n* Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy\n* Patient with severe hemorrhinopathy\n* Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants\n* Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months.\n* Patient with contraindication to necessary and pre-, per- or post-operative treatments\n* Follow-up of the patient seemed difficult by the investigator\n* Patient with insufficient oral hygiene incompatible with oral surgery'}, 'identificationModule': {'nctId': 'NCT04800250', 'acronym': 'Mucogreffe', 'briefTitle': 'Treatment of Multiple Gingival Recession Defects Using a New Xenogenic Collagen Membrane Compared to Connective Tissue Graft: a Randomized Controlled Split-mouth Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"', 'orgStudyIdInfo': {'id': '20-PP-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - Mucogain matrix on right', 'description': 'The patient will receive mucogain matrix on right side and connective tissue graft on left side.', 'interventionNames': ['Procedure: Treatment of gingival recessions']}, {'type': 'EXPERIMENTAL', 'label': 'B - Mucogain matrix on left', 'description': 'The patient will receive mucogain matrix on left side and connective tissue graft on right side.', 'interventionNames': ['Procedure: Treatment of gingival recessions']}], 'interventions': [{'name': 'Treatment of gingival recessions', 'type': 'PROCEDURE', 'description': 'Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure', 'armGroupLabels': ['A - Mucogain matrix on right', 'B - Mucogain matrix on left']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Séverine Vincent Bugnas', 'role': 'CONTACT', 'email': 'vincent-bugnas.s@chu-nice.fr', 'phone': '0492033270'}, {'name': 'Séverine VINCENT-BUGNAS, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Séverine I Vincent Bugnas', 'role': 'CONTACT', 'email': 'vincent-bugnas.s@chu-nice.fr', 'phone': '0492033270'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}