Clinical trial NCT03845621: Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players
Official title: Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Quality of Life
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of satisfaction using a questionnaire
timeFrame: Weeks 1-4
Secondary outcomes:
measure: Degree of interference on speech using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on breathing using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on swallowing using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort regarding the gag reflex using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort because the mouthguard fits too tight using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on aesthetics using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on athletic performance using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of protection using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of improvement on athletic performance using a questionnaire
timeFrame: Weeks 1-4
measure: Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard
timeFrame: Weeks 0-4
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Jordi Martinez-Gomis
state: Barcelona
Study officials:
References:
citation: Geary JL, Clifford TJ, Kinirons MJ. Occlusal accommodation and mouthguards for prevention of orofacial trauma. Oral Health Prev Dent. 2009;7(1):55-9.
citation: Zamora-Olave C, Willaert E, Montero-Blesa A, Riera-Punet N, Martinez-Gomis J. Risk of orofacial injuries and mouthguard use in water polo players. Dent Traumatol. 2018 Dec;34(6):406-412. doi: 10.1111/edt.12434. Epub 2018 Oct 10.
citation: Gomez-Gimeno A, Zamora-Olave C, Cordobes-Navarro M, Willaert E, Martinez-Gomis J. Satisfaction with shortening the palatal extension of a mouthguard for water polo players: A randomized crossover study. Dent Traumatol. 2019 Apr;35(2):135-141. doi: 10.1111/edt.12455. Epub 2019 Jan 7.
citation: Flores-Figueiras C, Zamora-Olave C, Willaert E, Martinez-Gomis J. Effect of thickness and occlusal accommodation on the degree of satisfaction with mouthguard use among water polo players: A randomized crossover trial. Dent Traumatol. 2020 Dec;36(6):670-679. doi: 10.1111/edt.12583. Epub 2020 Jul 20.