Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT05799859
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2023-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival recession height', 'timeFrame': '12 months postoperatively', 'description': 'Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin'}], 'secondaryOutcomes': [{'measure': 'Width of keratinized tissue (WKT)', 'timeFrame': '12 months postoperatively', 'description': 'Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction'}, {'measure': 'pocket probing depth (PPD)', 'timeFrame': '12 months postoperatively', 'description': 'Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus'}, {'measure': 'Clinical attachment loss (CAL)', 'timeFrame': '12 months postoperatively', 'description': 'Clinical attachment loss in millimeters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronally advanced flap', 'collagen', 'enamel matrix protein', 'dental enamel protein', 'gingival recession', 'periodontal plastic surgery'], 'conditions': ['Gingival Recession']}, 'descriptionModule': {'briefSummary': 'The clinical trial studies patients with gingival recession defects (receding gums).\n\nThe goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.', 'detailedDescription': 'The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.\n\nIn this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.\n\n15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent\n* able to achieve good oral hygiene (full mouth plaque score \\< 20 %, full mouth bleeding score \\< 20%),\n* patients presenting with at least one gingival recession defect\n\nExclusion Criteria:\n\n* general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);\n* ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;\n* self-reported heavy smokers (more than 10 cigarettes/day);\n* pregnancy and nursing mothers;\n* disorders or treatments that impair wound healing;\n* long-term treatment with high-dose steroids or anticoagulants;\n* bone metabolism disorders;\n* infections or vascular disorders in the region to be treated;\n* known hypersensitivity to porcine collagen;\n* patients with severe peripheral artery disease or autoimmune diseases;\n* extruded or malpositioned teeth.'}, 'identificationModule': {'nctId': 'NCT05799859', 'acronym': 'EmdoDerm', 'briefTitle': 'Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EmdoDerm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CAF + CM', 'description': 'Coronally advanced flap (CAF) and collagen matrix (CM)', 'interventionNames': ['Device: Use of coronally advanced flap (CAF) and collagen matrix (CM)']}, {'type': 'EXPERIMENTAL', 'label': 'CAF + CM +EMD', 'description': 'Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).', 'interventionNames': ['Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).']}], 'interventions': [{'name': 'Use of coronally advanced flap (CAF) and collagen matrix (CM)', 'type': 'DEVICE', 'armGroupLabels': ['CAF + CM']}, {'name': 'Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).', 'type': 'DEVICE', 'armGroupLabels': ['CAF + CM +EMD']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}