Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Trial Parameters
Brief Summary
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. The 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.
Eligibility Criteria
Inclusion Criteria: * Adult male or female ≥ 18 years (18th birthday completed) * Affiliation to a social welfare system * Signed informed consent form * More than 12 natural teeth suitable for evaluation * Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria Exclusion Criteria: * Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form) * Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s) * Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes) * Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region) * Current use of sonic toothbrush and/or dental water flosser * Severe manual handicap preventing the patient from holding a toothbrush with a large handle * Oral antiseptics (e.g. chlorhexidin mouthwashes) * Ongoing medica