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临床试验/NCT03845621
NCT03845621已完成不适用

Effect of Occlusal Accommodation 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 26 人开始时间: 2019年2月21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
26
试验地点
2
主要终点
Degree of satisfaction using a questionnaire

研究概览

简要总结

This study assesses the effect of adjusting the occlusal surface of a custom-made mouthguard on the degree of satisfaction with a mouthguard among water polo players. Twenty-four water polo players will wear a custom-made conventional mouthguard and a custom-made mouthguard with occlusal adjustment, two weeks per mouthguard. They will wear it during training sessions and for competing. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the conventional mouthguard, and the other half wearing the mouthguard with occlusal adjustment. The participants will rate the degree of interference with oral functions or discomfort in reference to speech, breathing, swallowing, gag reflex, fits too tight, fits too loose, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players also rated the perception of protection, the degree of improvement on athletic performance 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 aims to assess the effect of adjusting the occlusal surface of a custom-made mouthguard on the degree of satisfaction with a mouthguard among water polo players. Twenty-four water polo players will participate in this randomized crossover trial. Two different custom-made mouth guards will be made for each participant, a conventional one and an occlusal-adjusted mouthguard. Both types of mouthguard will be fabricated using a pressure molding device and 4-mm ethyl vinyl acetate foils. The conventional mouth guards will be made at 2 mm from the full depth of the labial sulcus, covering the second maxillary molar, and with the palatal margin extending 2 mm from the cervical line. To fabricate the occlusal adjusted mouthguard a second 2-mm foil of ethyl vinyl acetate will be formed over the initial 4-mm layer. The maxillary and mandibular casts mounted to an articulator using an inter occlusal record will facilitate the accommodation of the occlusal surface to the antagonistic teeth. The participants will be instructed to wear the mouth guards during training sessions and competitions. The sequence of use will be randomized to obtain one half of the participants beginning the first and the fourth week wearing the conventional mouthguard and the second and the third wearing the occlusal-adjusted mouthguard. The other half will start wearing the first and the fourth week the mouthguard with occlusal-adjusted mouthguard and the second and third week wearing the conventional mouthguard. The participants will evaluate on a 10-point scale for discomfort (gag reflex, fits too tight, fits too loose), interference with functions (speech, breathing, swallowing, aesthetics, and athletic performance), protection, and general satisfaction after each training session or match.

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

  • Playing in the highest Spanish league of water polo for the season 2018- 2019

排除标准

  • Players with dental caries, periodontitis or temporomandibular joint pain

结局指标

主要结局

Degree of satisfaction using a questionnaire

时间窗: Weeks 1-4

Participant satisfaction will be 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 breathing using a questionnaire(Weeks 1-4)
  • Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire(Weeks 1-4)
  • Degree of interference on aesthetics using a questionnaire(Weeks 1-4)
  • Degree of interference on swallowing using a questionnaire(Weeks 1-4)
  • Degree of discomfort regarding the gag reflex using a questionnaire(Weeks 1-4)
  • Degree of interference on speech using a questionnaire(Weeks 1-4)
  • Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard(Weeks 0-4)
  • Degree of interference on athletic performance using a questionnaire(Weeks 1-4)
  • Degree of protection using a questionnaire(Weeks 1-4)
  • Degree of improvement on athletic performance using a questionnaire(Weeks 1-4)
  • Degree of discomfort because the mouthguard fits too tight using a questionnaire(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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