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

  • End date
    Mar 1, 2024
  • participants needed
  • sponsor
    University Hospital, Strasbourg, France
Updated on 4 October 2022
vascular disease


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.

Condition Systemic sclerosis, Scleroderma
Treatment Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss), Sonic toothbrush, Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)
Clinical Study IdentifierNCT04627857
SponsorUniversity Hospital, Strasbourg, France
Last Modified on4 October 2022


Yes No Not Sure

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
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