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Completed

NCT Number: NCT03845621

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

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.

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Key information

Conditions

Satisfaction Behavior Personal Satisfaction Quality of Life

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Mouthguard

Device

Use of a conventional custom-made mouthguard while playing water polo

Occlusal-adjusted Mouthguard

Device

Use of an occlusal-adjusted custom-made mouthguard while playing water polo

Primary outcomes

  1. Degree of satisfaction using a questionnaire

    Time frame: Weeks 1-4

    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.

Secondary outcomes

  1. Degree of interference on speech using a questionnaire

    Time frame: Weeks 1-4

    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.

  2. Degree of interference on breathing using a questionnaire

    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= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.

  3. Degree of interference on swallowing using a questionnaire

    Time frame: Weeks 1-4

    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.

  4. Degree of discomfort regarding the gag reflex using a questionnaire

    Time frame: Weeks 1-4

    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.

  5. Degree of discomfort because the mouthguard fits too tight using a questionnaire

    Time frame: Weeks 1-4

    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.

  6. Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire

    Time frame: Weeks 1-4

    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.

  7. Degree of interference on aesthetics using a questionnaire

    Time frame: Weeks 1-4

    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.

  8. Degree of interference on athletic performance using a questionnaire

    Time frame: Weeks 1-4

    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.

  9. Degree of protection using a questionnaire

    Time frame: Weeks 1-4

    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.

  10. Degree of improvement on athletic performance using a questionnaire

    Time frame: Weeks 1-4

    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.

  11. Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard

    Time frame: Weeks 0-4

    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.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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