- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685318
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
May 24, 2022 updated by: Jordi Martinez-Gomis, University of Barcelona
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Jordi Martinez-Gomis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Use of a shortened custom-made mouthguard while playing water polo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weeks 1-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
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.
|
Weeks 1-4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1136/bjsm.2006.030874. 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
May 15, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
September 10, 2018
First Submitted That Met QC Criteria
September 22, 2018
First Posted (Actual)
September 26, 2018
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HOUB2018/004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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