Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Официальное название

Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances

Обзор

Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances. Thus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.

Вмешательства

• Устройство Sonicare Diamond Clean 9000
  Brush teeth with the electric toothbrush 1 daily during the orthodontic treatment
• Устройство HydroSonic Pro
  Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
• Устройство Oral-B 123
  Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment
• Устройство Curaprox CS 5460
  Brush teeth with the electric toothbrush 2 daily during the orthodontic treatment

Первичные конечные точки

• Incidence of gingival bleeding from baseline during orthodontic treatment [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]

Вторичные конечные точки (9)

• Acceptability [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Effect on gingival inflammation [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Effect on gingival bleeding [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Effect on dental plaque [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Effect on gingival tissue [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Effect on gingival attachment [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Enamel lesions [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Dentinal hypersensitivity [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]
• Salivary acidity [Срок оценки: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)]

Критерии участия

Критерии включения

• Children to be treated with fixed upper and lower braces
• 11 to 15 years of age at the start of treatment
• One parent/legal guardian agrees to the terms and conditions of the study and signs the informed consent form
• The adolescent agrees to the terms and conditions of the study and signs the informed consent form

Критерии исключения

• Less than 20 permanent teeth with braces or brackets
• Presence of untreated cavities
• Bleeding greater than 10% on probing
• Presence of a gingival pocket larger than 5 mm
• Presence of fixed prosthetic restorations
• Presence of any enamel development defect
• Presence of dental anomalies or direct/indirect labial restorations on teeth
• Patients requiring orthognathic surgeries
• Presence of systemic diseases (diabetes, hepatic, renal, hematologic, cardiovascular)
• Use of medications that may affect gingival health (such as calcium channel blockers, ciclosporin and anticoagulants)
• Use of antibiotics and anti-inflammatory drugs for any purpose over a long period of time.
• Having a smoking habit
• Having a physical or mental problem that affects manual dexterity
• Being unable to answer questions or being uncooperative

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Centre de soin dentaire — Nancy

Идентификаторы

NCT: NCT05851963 · ORTHO-IOP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗