Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05370456
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2022-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Recession Reduction (RecRed)', 'timeFrame': '6 months; 1 year', 'description': 'Mean changes in mm in recession depth between baseline and 1-year'}], 'secondaryOutcomes': [{'measure': 'Complete Root Coverage (CRC)', 'timeFrame': '6 months; 1 year', 'description': 'Percentage of sites with complete root coverage after 1-year'}, {'measure': 'Mean Root Coverage (MRC)', 'timeFrame': '6 months; 1 year', 'description': 'Percentage of mean root coverage after 1-year'}, {'measure': 'Keratinised tissue height (KTH) changes', 'timeFrame': '6 months; 1 year', 'description': 'Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year'}, {'measure': 'Post-operative morbidity (pain, swelling, discomfort)', 'timeFrame': '14 days', 'description': "Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession, Generalized']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old and able to sign informed consent\n* At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment\n* A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest\n* Available to attend study related procedures (including follow-up visits)\n\nExclusion Criteria:\n\n* Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);\n* Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;\n* Pregnant or nursing women;\n* History of previous periodontal surgery (mucogingival or other) on the teeth to be included;\n* Furcation involvement in the teeth to be included;\n* Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;\n* Presence of fixed or removable prosthesis in the area to be treated'}, 'identificationModule': {'nctId': 'NCT05370456', 'briefTitle': 'Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'The Adjunctive Use of Hyaluronic Acid for the Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap Plus Xenogeneic Collagen Matrix: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'XCM+HA_Turin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA)', 'description': 'Multiple coronally advanced flap technique (mCAF) with the use of a XCM in combination with local application of a HA gel', 'interventionNames': ['Device: Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xenogenic collagen matrix (XCM)', 'description': 'Multiple coronally advanced flap technique (mCAF) with the use of a XCM', 'interventionNames': ['Procedure: Treatment of MAGRs with mCAF technique and XCM']}], 'interventions': [{'name': 'Local application of a HA gel for the treatment of MAGRs with mCAF technique and XCM', 'type': 'DEVICE', 'description': 'After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction and HA gel will be applied.', 'armGroupLabels': ['Xenogenic collagen matrix (XCM) + Hyaluronic acid (HA)']}, {'name': 'Treatment of MAGRs with mCAF technique and XCM', 'type': 'PROCEDURE', 'description': 'After local anaesthesia, mCAF technique with two releasing vertical incisions will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction.', 'armGroupLabels': ['Xenogenic collagen matrix (XCM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Turin', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'centralContacts': [{'name': 'Mario Aimetti, PA', 'role': 'CONTACT', 'email': 'mario.aimetti@unito.it', 'phone': '00390116331541'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}