Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT07121361
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013281', 'term': 'Stomatitis, Aphthous'}, {'id': 'D014456', 'term': 'Ulcer'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-05', 'size': 453232, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T05:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '14 days', 'description': 'Pain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.'}, {'measure': 'Ulcers Dimensions', 'timeFrame': '14 days', 'description': 'Size of each ulcer measured through a sheet of clear plastic will be applied directly to the ulcer by tracing the circumference of the ulcer and then placed on a graph paper and the number of mm2 units included within the drawn area will be counted.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcers', 'Oral Hygiene', 'Oral care'], 'conditions': ['Recurrent Aphthous Ulcer', 'Recurrent Aphthous Stomatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of the present research is to evaluate the efficacy of a gel formulation for a total treatment of 14 days for the treatment of traumatic or aphthous oral ulcers.', 'detailedDescription': 'Primary Objective\n\nEvaluation of the clinical efficacy of the treatment using the following scores and clinical parameters:\n\nPain intensity, measured using the VAS (Visual Analogue Scale), consisting of a 10 cm line, where 0 indicates no pain and 10 indicates intense pain.\n\nSize of each ulcer.\n\nSecondary Objectives\n\nEvaluation of the following scores and clinical parameters:\n\n1. Registration of the superficial temperature of the mucous membranes using Infrared Thermography.\n2. Ulcer Severity Score (USS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with at least one well-defined oral ulcer.\n* Patients with no cognitive disorders able to provide mouthwash treatment independently\n\nExclusion Criteria:\n\n* Proven intolerance or allergy to the product.\n* Patients with a hematological deficit such as anemia, iron deficiency, vitamin B12 and/or folic acid\n* No systemic diseases including ulcerative colitis, Crohn's disease, Behçet's syndrome with recurrent aphthous lesions; alcohol and tobacco consumption;\n* No history of allergies;\n* No previously treatment of oral ulcers with topical steroids, vitamins, antibiotics, antihistamines, oral retinoids, or immunomodulatory agents within three months prior to entering the study;\n* No non-steroidal anti-inflammatory drugs or mouthwash administrations for the treatment of the ulcer within 72 hours before entering the study.\n* Pregnants or breastfeeding patients."}, 'identificationModule': {'nctId': 'NCT07121361', 'acronym': 'RASMA', 'briefTitle': 'Effectiveness of Recurrent Aphthous Stomatitis Mouthwash System for the Treatment of Oral Ulcers', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': 'Evaluation of the Efficacy of a Mouthwash Formulation for Minor Oral Ulcers: A Triple-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RA/0362820'}, 'secondaryIdInfos': [{'id': 'RA/0362820', 'type': 'OTHER', 'domain': 'Territorial Ethics Committee of the Abruzzi Region, Italy (C.Et.R.A.) )'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DNA mouthwash', 'description': 'The compound is characterized by a formulation that ensures effective action on the film-forming component. The presence of DNA fractions increases the viscosity of the solutions and increases the hydration of the mucous membranes with a consequent improvement in trophism for oral ulcers.\n\nThe treatment indications are to delay and prevent oral ulcers and the formation of bacterial plaque; prevent irritation of the gums and oral cavity, even in wearers of prostheses and orthodontic implants accompanied by problems with dental support structures; after tooth extraction; before and after any dental surgery. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days', 'interventionNames': ['Device: Mouthwash Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo mouthwash', 'description': 'The placebo will be deprived by all components. The patients will be instructed to rinse the mouth and ulcers with the mouthwash twice a day after oral hygiene for 14 days', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'Mouthwash Product', 'type': 'DEVICE', 'description': 'DNA mouthwash', 'armGroupLabels': ['DNA mouthwash']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'Placebo mouthwash', 'armGroupLabels': ['Placebo mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'state': 'Abruzzo', 'country': 'Italy', 'facility': 'University of Chieti- Department of Innovative Technology in Medicine and Dentistry', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], 'overallOfficials': [{'name': 'Prof. Antonio Scarano Antonio Scarano, MD DDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Innovative Technology in Medicine and Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher, Department of Innovative Technologies in Medicine and Dentistry, University "G.d\'Annunzio" of Chieti-Pescara', 'investigatorFullName': 'Felice Lorusso', 'investigatorAffiliation': "G. d'Annunzio University"}}}}