Department of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
Centre for Craniofacial Development & Regeneration, Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, UK.
Eur J Orthod. 2022 Jan 25;44(1):101-109. doi: 10.1093/ejo/cjab062.
Orthodontic patients wearing fixed appliances are susceptible to traumatic dental injuries during a wide range of sporting activities. This randomized clinical trial investigated wearability and preference of mouthguards during sporting activities in patients undergoing orthodontic treatment with fixed appliances.
A prospective three-arm crossover randomized clinical trial conducted in the UK. Thirty patients in active orthodontic treatment with fixed appliances undertaking at least 120 minutes of contact sport per 6-8-week observation period were randomly assigned to one of six mouthguard allocation sequences consisting of three mouthguard types: (MG1) custom-made laboratory constructed, (MG2) mouth-formed OPRO® Gold Braces, and (MG3) pre-fabricated Shock Doctor® Single Brace. Patients completed a nine-outcome 100-mm visual analogue scale (VAS) questionnaire relating to mouthguard wearability during sport. Once feedback was completed, subjects were allocated the next mouthguard in the sequence. At study-end, subjects were asked to identify their preferred mouthguard.
Twenty-four patients (median age = 13; inter-quartile range 12-14.5 years) completed n = 72 follow-up questionnaires with most playing rugby union or field hockey. Considering VAS score as a continuous variable, for comfort, stability, hardness, ability to breathe, ability to not cause nausea, and inclination to chew, MG2 performed better than MG3. For categorization of VAS score into low (less than 80 mm) or high (at least 80 mm) wearability, for comfort, stability, ability to not cause nausea, and inclination to chew, MG1 and MG2 also rated superior to MG3. Patients preferred MG1 overall.
This randomized clinical trial found that during contact sport patients in fixed appliances reported superior wearability for custom-made and mouth-formed mouthguards in comparison to pre-fabricated. Overall, patients preferred custom-made mouthguards.
ClinicalTrials.gov: NCT04588831.
佩戴固定矫治器的正畸患者在进行各种运动时容易发生外伤性牙损伤。本随机临床试验研究了在接受固定矫治器正畸治疗的患者进行运动时，使用各种类型的护齿器的佩戴舒适性和偏好性。
在英国进行的前瞻性三臂交叉随机临床试验。30 名正在接受固定矫治器正畸治疗且每 6-8 周观察期内至少进行 120 分钟接触性运动的患者被随机分配到 6 种护齿器分配序列中的 1 种，这些序列包含 3 种护齿器类型：（MG1）定制实验室制作、（MG2）口内成型 OPRO® Gold Braces 和（MG3）预制 Shock Doctor®Single Brace。患者在运动时完成了 9 项 100mm 视觉模拟量表（VAS）问卷，以评估护齿器的佩戴舒适性。一旦完成反馈，患者将被分配到下一个序列中的护齿器。在研究结束时，要求患者识别他们喜欢的护齿器。
24 名患者（中位数年龄=13 岁；四分位距 12-14.5 岁）完成了 n = 72 次随访问卷，其中大多数人参加橄榄球或曲棍球运动。考虑到 VAS 评分作为连续变量，在舒适度、稳定性、硬度、呼吸能力、不引起恶心的能力以及咀嚼倾向方面，MG2 优于 MG3。对于 VAS 评分分为低（小于 80mm）或高（至少 80mm）佩戴舒适性，在舒适度、稳定性、不引起恶心的能力和咀嚼倾向方面，MG1 和 MG2 也优于 MG3。患者总体上更喜欢 MG1。
本随机临床试验发现，在接触性运动中，与预制护齿器相比，固定矫治器患者报告定制和口内成型护齿器的佩戴舒适性更高。总体而言，患者更喜欢定制护齿器。
ClinicalTrials.gov：NCT04588831。
