Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

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)

Treatment groups

100 Participants
are divided into 4 treatment groups