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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Changing of plaque index between baseline, week 2 and week 4 [Срок оценки: day 0, week 2 and week 4]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Service de parodontologie — Strasbourg

Идентификаторы

NCT: NCT04627857 · 8014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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