Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
研究概览
简要总结
The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly.
Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment.
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
详细描述
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for <= 25 aligners to complete treatment.
- •Treatment must be dual arch in order for patients to qualify for this study.
- •Patients must be 18 years or older
排除标准
- •Patients with systematic diseases or syndromes
- •Patients with a history or current use of Bisphosphonates
- •Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors.
- •Patients with generalized moderate to severe periodontitis
- •Patients with active oral hard tissue or soft tissue lesions
- •Patients with chronic oral and maxillofacial conditions such as trigeminal neuralgia, temporomandibular disorder and orofacial pain.
结局指标
主要结局
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
时间窗: 6 months
The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.
次要结局
- Final Alignment Scores of the Upper and Lower Incisors(6 months)
研究者
Greg Huang
Professor, Orthodontics
University of Washington