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

• ClinicalTrials.gov Identifier: NCT03685318
• Recruitment Status: Completed
• First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Sponsor: University of Barcelona
• Information provided by (Responsible Party): Jordi Martinez-Gomis, University of Barcelona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mouth Protectors; Quality of Life	Device: Use of conventional mouthguard; Device: Use of shortened mouthguard	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study
• Actual Study Start Date: March 1, 2018
• Actual Primary Completion Date: May 15, 2018
• Actual Study Completion Date: June 15, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Use of conventional mouthguard; Use of a conventional custom-made mouthguard while playing water polo
Active Comparator: 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.	Device: Use of shortened mouthguard; Use of a shortened custom-made mouthguard while playing water polo

Outcome Measures

Primary Outcome Measures :

1. Degree of satisfaction with the mouthguard [ Time Frame: Weeks 1-4 ]
   Participant satisfaction was 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.

Secondary Outcome Measures :

1. Degree of interference on speech while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of interference on speech while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to speech?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
2. Degree of interference on breathing while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of interference on breathing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to breath?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
3. Degree of interference on swallowing while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of interference on swallowing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to swallow?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
4. Degree of discomfort regarding the gag reflex while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of discomfort regarding the gag reflex while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard causes a gag reflex?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
5. Degree of discomfort because the mouthguard fits too tight [ Time Frame: Weeks 1-4 ]
   The degree of discomfort because the mouthguard fits too tight was assessed by asking the question "How much do you think the mouthguard fits too tight?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
6. Degree of discomfort because the mouthguard fits too loose [ Time Frame: Weeks 1-4 ]
   The degree of discomfort because the mouthguard fits too loose was assessed by asking the question "How much do you think the mouthguard fits too loose?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
7. Degree of interference on aesthetics while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of interference on aesthetics while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes on aesthetics?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
8. Degree of interference on athletic performance while using the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of interference on athletic performance while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes athletic performance?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.
9. Degree of protection with the mouthguard [ Time Frame: Weeks 1-4 ]
   The degree of protection perceived by the participant was assessed by asking the question "How much do you feel protected when you are wearing the mouthguard?" using a 0-10 point scale (considering 0= Not at all to 10= very much). Players rated the mouthguard just after each training session or after each match.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Spain

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Sponsors and Collaborators

University of Barcelona

More Information

Publications:

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.

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.

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. Epub 2006 Sep 25.

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. Review.

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. Review.

• Responsible Party: Jordi Martinez-Gomis, Associate Professor DDS. PhD, University of Barcelona
• ClinicalTrials.gov Identifier: NCT03685318
• Other Study ID Numbers: HOUB2018/004
• First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No