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

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Scleroderma Systemic

Treatments: Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Sonic toothbrush; Device: Manual toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)

Study type: Interventional

Funder types: Other

Identifiers

NCT04627857

8014 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Arm 1: Manual toothbrush

Active Comparator group

Treatment:

Device: Manual toothbrush

Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)

Experimental group

Treatment:

Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss)

Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra)

Experimental group

Treatment:

Device: Sonic toothbrush

Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser

Experimental group

Treatment:

Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)