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

Quality of Life Clinical Trial

Official title:

Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845621
• Other study ID #: HOUB2018/031
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: July 10, 2019

Study information

• Verified date: May 2022
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 10, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Satisfaction

Intervention

Device:
• Conventional Mouthguard
Use of a conventional custom-made mouthguard while playing water polo
• Occlusal-adjusted Mouthguard
Use of an occlusal-adjusted custom-made mouthguard while playing water polo

Locations

Country	Name	City	State
Spain	Jordi Martinez-Gomis	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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):670-6 — View 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. — View Citation

Gómez-Gimeno À, Zamora-Olave C, Cordobés-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of satisfaction using a questionnaire	Participant satisfaction will be 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.	Weeks 1-4
Secondary	Degree of interference on speech using a questionnaire	The degree of interference on speech while using the mouthguard will be 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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of interference on breathing using a questionnaire	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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of interference on swallowing using a questionnaire	The degree of interference on swallowing while using the mouthguard will be 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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of discomfort regarding the gag reflex using a questionnaire	The degree of discomfort regarding the gag reflex while using the mouthguard will be 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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of discomfort because the mouthguard fits too tight using a questionnaire	The degree of discomfort because the mouthguard fits too tight will be assessed by asking the question "How much do you think the mouthguard fits too tight?" using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire	The degree of discomfort because the mouthguard dislodges will be assessed by asking the question "How much do you think the mouthguard fits too loose?" using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of interference on aesthetics using a questionnaire	The degree of interference on aesthetics while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes on aesthetics?" using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of interference on athletic performance using a questionnaire	The degree of interference on athletic performance while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes athletic performance?" using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of protection using a questionnaire	The degree of protection perceived by the participant will be 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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Degree of improvement on athletic performance using a questionnaire	The degree of improvement on athletic performance while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard improves athletic performance?" using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.	Weeks 1-4
Secondary	Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard	The time spent in both the laboratory and the clinical setting and the cost of the materials will be considered for the estimation of the cost-effectiveness of the mouthguard. Effectiveness will be considered as the degree of satisfaction with the mouthguard perceived by the participant.	Weeks 0-4