Clinical trial NCT03685318: Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
Official title: Effect of Shortening the Palatal Extension 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: Mouth Protectors
Quality of Life
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 18
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 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.

Detailed description: 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.

Eligibility criteria: 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)

Exclusion Criteria:

* Players with dental caries, with periodontitis or with temporomandibular joint pain

Primary outcomes:
measure: Degree of satisfaction with the mouthguard
timeFrame: Weeks 1-4
Secondary outcomes:
measure: Degree of interference on speech while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of interference on breathing while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of interference on swallowing while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of discomfort regarding the gag reflex while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of discomfort because the mouthguard fits too tight
timeFrame: Weeks 1-4
measure: Degree of discomfort because the mouthguard fits too loose
timeFrame: Weeks 1-4
measure: Degree of interference on aesthetics while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of interference on athletic performance while using the mouthguard
timeFrame: Weeks 1-4
measure: Degree of protection with the mouthguard
timeFrame: Weeks 1-4
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Jordi Martinez-Gomis
state: Barcelona
Study officials:
References:
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: Gebauer DP, Williamson RA, Wallman KE, Dawson BT. The effect of mouthguard design on respiratory function in athletes. Clin J Sport Med. 2011 Mar;21(2):95-100. doi: 10.1097/JSM.0b013e31820428b0.
citation: Maeda Y, Machi H, Tsugawa T. Influences of palatal side design and finishing on the wearability and retention of mouthguards. Br J Sports Med. 2006 Dec;40(12):1006-8. doi: 10.1136/bjsm.2006.030874. Epub 2006 Sep 25.
citation: Lloyd JD, Nakamura WS, Maeda Y, Takeda T, Leesungbok R, Lazarchik D, Dorney B, Gonda T, Nakajima K, Yasui T, Iwata Y, Suzuki H, Tsukimura N, Churei H, Kwon KR, Choy MMH, Rock JB. Mouthguards and their use in sports: Report of the 1st International Sports Dentistry Workshop, 2016. Dent Traumatol. 2017 Dec;33(6):421-426. doi: 10.1111/edt.12375.
citation: Parker K, Marlow B, Patel N, Gill DS. A review of mouthguards: effectiveness, types, characteristics and indications for use. Br Dent J. 2017 Apr 21;222(8):629-633. doi: 10.1038/sj.bdj.2017.365.
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.