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临床试验/NCT05238480
NCT05238480已完成不适用

Effect of Hard Labial Reinforcement of a Custom-made Mouthguard on the Degree of Satisfaction Among Rugby Players. A Randomized Crossover Study

University of Barcelona2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年2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
24
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 incorporating a hard labial layer to the front zone of a custom-made mouthguard on the degree of satisfaction of rugby players. Twenty-four rugby players will wear a custom-made Bioplast Xtreme conventional mouthguard (Bioplast Xtreme 4 × 125 + Bioplast 2 x 125; Scheu-Dental Company) and a custom-made Bioplast Xtreme Pro mouthguard (Bioplast Xtreme 4mm × 125 + Duran Layer 0.75mm; Bioplast 2mm x 125), two weeks per mouthguard. They will wear it during training sessions and competitions. The sequence will be randomized for one-half of the participants to start wearing the Bioplast Xtreme conventional and the other half the Bioplast Xtreme Pro mouthguard the first week.

The participants will rate the degree of interference with oral functions or discomfort in reference to speeking, breathing, swallowing, gag reflex, tight or loose fitting, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players will also rate the perception of the 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 incorporating a hard labial layer to the front zone of a custom-made mouthguard on the degree of satisfaction of rugby players. Twenty-four rugby players will participate in this randomized crossover trial. Three hydrocolloid impressions will be made, two of their maxillary arches and one of their mandibular arches, and the casts will be poured immediately with Type IV dental stone. An interocclusal record will be obtained using an extra hard wax covering the tip of two wooden tongue depressors to assure a near centric relation and a minimum interocclusal distance of approximately 2 mm. Two different custom-made mouth guards will be made for each participant, a Bioplast Xtreme conventional mouthguard (Bioplast Xtreme 4 × 125 + Bioplast 2 x 125; Scheu-Dental Company) and a custom-made Bioplast Xtreme Pro mouthguard (Bioplast Xtreme 4mm × 125 + Duran Layer 0.75mm; Bioplast 2mm x 125). Conventional mouthguard will be fabricated using a pressure molding device and a 4-mm ethyl vinyl acetate foil 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 adjustment 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 the inter occlusal record will facilitate the accommodation of the occlusal surface to the antagonistic teeth. Bioplast Xtreme Pro will be made by the same procedure, except the incorporation of an extra layer of Duran between 4mm ethyl vinyl acetate foil and 2 mm ethyl vinyl acetate foil. 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 wearing Xtreme Conventional mouthguard the first and the fourth week and the Xtreme Pro mouthguard the second and the third week. The other half will start wearing the first and the fourth week the Xtreme Pro mouthguard and the second and third week the Xtreme conventional mouthguard. The participants will evaluate using a 10-point scale the discomfort (gag reflex, tight or loose fitting), the level of interference with functions (speeking, breathing, swallowing, aesthetics and athletic performance), the protection, and the 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 Catalan/Spanish league of rugby for the season 2021-2022

排除标准

  • Presence of dental caries
  • Players with periodontitis,
  • Players with temporomandibular joint pain
  • Players with active orthodontic treatment

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 discomfort regarding the gag reflex using a questionnaire(Weeks 1-4)
  • Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard(Weeks 1-4)
  • Degree of interference on speech using a questionnaire(Weeks 1-4)
  • Degree of interference on breathing using a questionnaire(Weeks 1-4)
  • Degree of interference on swallowing using a questionnaire(Weeks 1-4)
  • Degree of discomfort because the mouthguard fits too tight 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 athletic performance using a questionnaire(Weeks 1-4)
  • Degree of protection 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, Serra Hunter Fellow, Department of Prosthodontics

University of Barcelona

研究点 (2)

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