Overview
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
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 medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
- Smoking (≥ 10 cigarettes per day)
- Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
- Individual under guardianship, curatorship or judicial protection