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临床试验/NCT03685318
NCT03685318已完成不适用

Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study

University of Barcelona2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Degree of satisfaction with the mouthguard

研究概览

简要总结

This study assessed the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo players wore a custom-made conventional mouthguard or a reduced palate extension mouthguard during the training sessions and for competing for two weeks. The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard. The participants rated the degree of discomfort in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort and 10 maximum discomfort. After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.

详细描述

This crossover intervention study aimed to assess the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo players participated in this study. Two different custom-made mouthguards were made, a conventional one and a reduced palate extension mouthguard. They wore them during the training sessions and for competing one type of mouthguard for the first and fourth week and the other type of mouthguard for the second and third week. The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard. The participants rated the degree of discomfort or inconvenience in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort/inconvenience and 10 maximum discomfort/inconvenience. After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • water polo players playing in maximum Spanish category for the season 2017-2018
  • Obtaining written informed consent for participating in the project (model consent form)

排除标准

  • Players with dental caries, with periodontitis or with temporomandibular joint pain

结局指标

主要结局

Degree of satisfaction with the mouthguard

时间窗: Weeks 1-4

Participant satisfaction was assessed by asking the question "How satisfied are you with your mouthguard?" using a 0-10 point scale, considering 0= totally dissatisfied and 10= totally satisfied. Players rated the mouthguard just after each training session or after each match.

次要结局

  • Degree of interference on speech while using the mouthguard(Weeks 1-4)
  • Degree of interference on swallowing while using the mouthguard(Weeks 1-4)
  • Degree of interference on athletic performance while using the mouthguard(Weeks 1-4)
  • Degree of interference on breathing while using the mouthguard(Weeks 1-4)
  • Degree of discomfort regarding the gag reflex while using the mouthguard(Weeks 1-4)
  • Degree of discomfort because the mouthguard fits too loose(Weeks 1-4)
  • Degree of protection with the mouthguard(Weeks 1-4)
  • Degree of discomfort because the mouthguard fits too tight(Weeks 1-4)
  • Degree of interference on aesthetics while using the mouthguard(Weeks 1-4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordi Martinez-Gomis

Associate Professor DDS. PhD

University of Barcelona

研究点 (2)

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