Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mouth Protectors Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional mouthguard

Use of a conventional custom-made mouthguard while playing water polo for two weeks. The conventional mouthguard is designed with the palatal margin at 6 mm from the cervical line.

Group Type ACTIVE_COMPARATOR

Use of conventional mouthguard

Intervention Type DEVICE

Use of a conventional custom-made mouthguard while playing water polo

Shortened mouthguard

Use of a shortened custom-made mouthguard while playing water polo for two weeks. The shortened mouthguard is designed with the palatal margin at 2 mm from the cervical line.

Group Type ACTIVE_COMPARATOR

Use of shortened mouthguard

Intervention Type DEVICE

Use of a shortened custom-made mouthguard while playing water polo

Interventions

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Use of conventional mouthguard

Use of a conventional custom-made mouthguard while playing water polo

Intervention Type DEVICE

Use of shortened mouthguard

Use of a shortened custom-made mouthguard while playing water polo

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)