Comparison of the Effectiveness of Manual and Electric Toothbrushes in Daily Practice in Patients With Fixed Orthodontic Appliances
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of gingival bleeding from baseline during orthodontic treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group using manual toothbrush with 5460 strands
Patients will be asked to use a manual toothbrush with 5460 strands for 24 months
干预措施: Curaprox CS 5460 (Device)
Group using sonic toothbrush
Patients will be asked to use a sonic toothbrush for 24 months
干预措施: Sonicare Diamond Clean 9000 (Device)
Group using hydrosonic toothbrush
Patients will be asked to use a hydrosonic toothbrush for 24 months
干预措施: HydroSonic Pro (Device)
Group using manual toothbrush
Patients will be asked to use a manual toothbrush for 24 months
干预措施: Oral-B 123 (Device)
结局指标
主要结局
Incidence of gingival bleeding from baseline during orthodontic treatment
时间窗: T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months)
Change of gingival inflammation in patients with fixed orthodontic appliances using manual or electric toothbrushes in daily practice
次要结局
- Acceptability(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(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(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(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(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(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(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(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(T1 (1 month), T2 (+ 3 months) and T3 (+ 6 months), T4 (+ 12 months), T5 (+ 15 months) T6 (+ 18 months) and T7 (+ 24 months))
研究者
Carrouel Florence
Associate professor
Claude Bernard University