About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Manual toothbrush
- Manual toothbrush and water flosser (Philips Sonicare AirFloss)
- Sonic toothbrush
- Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)