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Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players

24. mai 2022 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spania, 08907
        • Jordi Martinez-Gomis

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Degree of satisfaction with the mouthguard
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Degree of interference on speech while using the mouthguard
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

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Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2018

Primær fullføring (Faktiske)

15. mai 2018

Studiet fullført (Faktiske)

15. juni 2018

Datoer for studieregistrering

Først innsendt

10. september 2018

Først innsendt som oppfylte QC-kriteriene

22. september 2018

Først lagt ut (Faktiske)

26. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HOUB2018/004

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Nei

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