Mouth ProtectorsNCT03685318
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
A study testing Use of conventional mouthguard and Use of shortened mouthguard in people with Mouth Protectors and Quality of Life, run by University of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Protectors, Quality of Life
- What is being tested?
- Use of conventional mouthguard and Use of shortened mouthguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Players with dental caries, with periodontitis or with temporomandibular joint pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mouth Protectors, Quality of Life
- Being tested
- Use of conventional mouthguard, Use of shortened mouthguard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of conventional mouthguardDevice
Use of a conventional custom-made mouthguard while playing water polo
Use of shortened mouthguardDevice
Use of a shortened custom-made mouthguard while playing water polo
| Study group | Role | What they receive |
|---|---|---|
| Conventional mouthguard | Active comparator | 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. Receives: Device: Use of conventional mouthguard |
| Shortened mouthguard | Active comparator | 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. Receives: Device: Use of shortened mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of satisfaction with the mouthguard
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.
Measured: Weeks 1-4
Secondary outcomes (9)
Degree of interference on speech while using the mouthguard
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.
Measured: Weeks 1-4
Degree of interference on breathing while using the mouthguard
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.
Measured: Weeks 1-4
Degree of interference on swallowing while using the mouthguard
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.
Measured: Weeks 1-4
Degree of discomfort regarding the gag reflex while using the mouthguard
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.
Measured: Weeks 1-4
Degree of discomfort because the mouthguard fits too tight
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.
Measured: Weeks 1-4
Degree of discomfort because the mouthguard fits too loose
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.
Measured: Weeks 1-4
Degree of interference on aesthetics while using the mouthguard
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.
Measured: Weeks 1-4
Degree of interference on athletic performance while using the mouthguard
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.
Measured: Weeks 1-4
Degree of protection with the mouthguard
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.
Measured: Weeks 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Mar 2018
- Primary completion15 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mouth ProtectorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Martinez-Gomis, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685318
- Sponsor's protocol ID
- HOUB2018/004
- Status last verified
- May 2022
- First submitted
- 10 Sep 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30156365Gebauer 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.
PubMed 21358498Maeda 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.
PubMed 17000712Lloyd 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.
PubMed 28965361Parker 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.
PubMed 28428580Gomez-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.
PubMed 30481393
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03685318
- Acronym / sponsor ID
- HOUB2018/004
- Conditions
- Mouth Protectors, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional mouthguard | Active comparator | Device: Use of conventional mouthguardUse 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. |
| Shortened mouthguard | Active comparator | Device: Use of shortened mouthguardUse 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Players with dental caries, with periodontitis or with temporomandibular joint pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of conventional mouthguardUse of a conventional custom-made mouthguard while playing water polo | Device | Conventional mouthguard |
| Use of shortened mouthguardUse of a shortened custom-made mouthguard while playing water polo | Device | Shortened mouthguard |
Primary outcome
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.
9 secondary outcomes
Degree of interference on speech while using the mouthguard
Time frame: Weeks 1-4
Degree of interference on breathing while using the mouthguard
Time frame: Weeks 1-4
Degree of interference on swallowing while using the mouthguard
Time frame: Weeks 1-4
Degree of discomfort regarding the gag reflex while using the mouthguard
Time frame: Weeks 1-4
Degree of discomfort because the mouthguard fits too tight
Time frame: Weeks 1-4
Degree of discomfort because the mouthguard fits too loose
Time frame: Weeks 1-4
Degree of interference on aesthetics while using the mouthguard
Time frame: Weeks 1-4
Degree of interference on athletic performance while using the mouthguard
Time frame: Weeks 1-4
Degree of protection with the mouthguard
Time frame: Weeks 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Background: PubMed 30156365Zamora-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.
- Background: PubMed 21358498Gebauer 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.
- Background: PubMed 17000712Maeda 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.
- Background: PubMed 28965361Lloyd 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.
- Background: PubMed 28428580Parker 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.
- Results publication: PubMed 30481393Gomez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of conventional mouthguard and Use of shortened mouthguard in people with Mouth Protectors and Quality of Life, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of satisfaction with the mouthguard (time frame: Weeks 1-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685318, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.