Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy: a Single-center, Single Blind Randomized Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Comfort and wearability of all three mouthguards
研究概览
简要总结
There is no current evidence on the comfort or wearability of orthodontic mouthguards. These mouthguards adapt to the mouth without the need for dental impressions and laboratory facilities and are suggested to be more comfortable for orthodontic patients by allowing the teeth to move during treatment without the need for them to be replaced regularly during treatment. This study aims to assess and compare the comfort and wearability of orthodontic mouthguards with custom-fitted mouthguards. The results of this study will allow orthodontists to provide evidence-based information to individuals undergoing fixed appliance therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing active orthodontic treatment with pre-adjusted edgewise fixed appliances only for a minimum period of 9 months
- •Playing sports where the use of a mouthguard is recommended
- •Playing at least 120 minutes of sport (match or training) during a 6-8 week period
- •Class I, II or mild III (edge-to-edge) incisor malocclusion
- •Able to complete a VAS questionnaire
- •No diagnosed sensory processing disorder
排除标准
- •Undergoing active orthodontic treatment that is not pre-adjusted edgewise fixed appliances, or requires a fixed expander, or treatment is likely to be completed within 9 months
- •Playing sports where the use of a mouthguard is not recommended Playing less than 120 minutes of sport (match or training) during a 6-8 week period
- •Moderate to severe class III (reverse overjet) incisor malocclusion
- •Unable to complete a VAS questionnaire
- •Have a diagnosed sensory processing disorder
结局指标
主要结局
Comfort and wearability of all three mouthguards
时间窗: 4 years
The primary and only outcome of this study was the response to each question of the administered questionnaire.
次要结局
未报告次要终点