Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
24 mei 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanje, 08907
- Jordi Martinez-Gomis
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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Use of a conventional custom-made mouthguard while playing water polo
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Actieve vergelijker: 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.
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Use of a shortened custom-made mouthguard while playing water polo
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Degree of satisfaction with the mouthguard
Tijdsspanne: Weeks 1-4
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Degree of interference on speech while using the mouthguard
Tijdsspanne: 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
|
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Degree of interference on breathing while using the mouthguard
Tijdsspanne: 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
Tijdsspanne: 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
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Degree of discomfort regarding the gag reflex while using the mouthguard
Tijdsspanne: 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.
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Weeks 1-4
|
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Degree of discomfort because the mouthguard fits too tight
Tijdsspanne: 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
|
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Degree of discomfort because the mouthguard fits too loose
Tijdsspanne: 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
|
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Degree of interference on aesthetics while using the mouthguard
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2018
Primaire voltooiing (Werkelijk)
15 mei 2018
Studie voltooiing (Werkelijk)
15 juni 2018
Studieregistratiedata
Eerst ingediend
10 september 2018
Eerst ingediend dat voldeed aan de QC-criteria
22 september 2018
Eerst geplaatst (Werkelijk)
26 september 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 mei 2022
Laatste update ingediend die voldeed aan QC-criteria
24 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- HOUB2018/004
Plan Individuele Deelnemersgegevens (IPD)
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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