Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

24 de maio de 2022 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

18

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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
Comparador Ativo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Degree of satisfaction with the mouthguard
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Degree of interference on speech while using the mouthguard
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2018

Conclusão Primária (Real)

15 de maio de 2018

Conclusão do estudo (Real)

15 de junho de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de setembro de 2018

Primeira postagem (Real)

26 de setembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de maio de 2022

Última verificação

1 de maio de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HOUB2018/004

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever