Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 6:07 PM
Study NCT ID:
NCT04627857
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changing of plaque index between baseline, week 2 and week 4', 'timeFrame': 'day 0, week 2 and week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scleroderma Systemic']}, 'descriptionModule': {'briefSummary': 'Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.\n\nThe aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female ≥ 18 years (18th birthday completed)\n* Affiliation to a social welfare system\n* Signed informed consent form\n* More than 12 natural teeth suitable for evaluation\n* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria\n\nExclusion Criteria:\n\n* Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)\n* Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)\n* Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)\n* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)\n* Current use of sonic toothbrush and/or dental water flosser\n* Severe manual handicap preventing the patient from holding a toothbrush with a large handle\n* Oral antiseptics (e.g. chlorhexidin mouthwashes)\n* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)\n* Smoking (≥ 10 cigarettes per day)\n* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)\n* Individual under guardianship, curatorship or judicial protection'}, 'identificationModule': {'nctId': 'NCT04627857', 'acronym': 'ScleroBross', 'briefTitle': 'Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis', 'orgStudyIdInfo': {'id': '8014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Manual toothbrush', 'interventionNames': ['Device: Manual toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)', 'interventionNames': ['Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)', 'interventionNames': ['Device: Sonic toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser', 'interventionNames': ['Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)']}], 'interventions': [{'name': 'Manual toothbrush', 'type': 'DEVICE', 'description': "Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.", 'armGroupLabels': ['Arm 1: Manual toothbrush']}, {'name': 'Manual toothbrush and water flosser (Philips Sonicare AirFloss)', 'type': 'DEVICE', 'description': '\\- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.', 'armGroupLabels': ['Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)']}, {'name': 'Sonic toothbrush', 'type': 'DEVICE', 'description': '\\- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.', 'armGroupLabels': ['Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)']}, {'name': 'Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)', 'type': 'DEVICE', 'description': '\\- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.', 'armGroupLabels': ['Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie JUNG', 'role': 'CONTACT'}], 'facility': 'Service de parodontologie', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Sophie JUNG', 'role': 'CONTACT', 'email': 'sophie.jung1@chru-strasbourg.fr', 'phone': '00333.88.11.69.56'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}