Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult male or female ≥ 18 years (18th birthday completed) - Affiliation to a social welfare system - Signed willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Manual toothbrush

Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.

DEVICE

Manual toothbrush and water flosser (Philips Sonicare AirFloss)

\- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.

DEVICE

Sonic toothbrush

\- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.

DEVICE

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

\- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.

Locations (1)

Service de parodontologie
Strasbourg, France