Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players

University of Barcelona

Status: Completed

Conditions: Quality of Life; Satisfaction

Treatments: Device: Occlusal-adjusted Mouthguard; Device: Conventional Mouthguard

Study type: Interventional

Funder types: Other

Identifiers

NCT03845621

HOUB2018/031

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Players with dental caries, periodontitis or temporomandibular joint pain

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

CM-OA-OA-CM Sequence

Active Comparator group

Description:

Use of a conventional custom-made mouthguard (CM) while playing water polo for first and fourth weeks and the occlusal-adjusted custom-made mouthguard (OA) for the second and third weeks.

Treatment:

Device: Occlusal-adjusted Mouthguard

Device: Conventional Mouthguard

OA-CM-CM-OA Sequence

Active Comparator group

Description:

Use of an occlusal-adjusted custom-made mouthguard (OA) for the first and fourth weeks and a conventional custom-made mouthguard (CM) while playing water polo for the second and third weeks.

Treatment:

Device: Occlusal-adjusted Mouthguard

Device: Conventional Mouthguard