Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
24. Mai 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
18
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Jordi Martinez-Gomis
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver 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.
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Use of a conventional custom-made mouthguard while playing water polo
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Aktiver 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.
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Use of a shortened custom-made mouthguard while playing water polo
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Degree of satisfaction with the mouthguard
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Degree of interference on speech while using the mouthguard
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2018
Primärer Abschluss (Tatsächlich)
15. Mai 2018
Studienabschluss (Tatsächlich)
15. Juni 2018
Studienanmeldedaten
Zuerst eingereicht
10. September 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. September 2018
Zuerst gepostet (Tatsächlich)
26. September 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Mai 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Mai 2022
Zuletzt verifiziert
1. Mai 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- HOUB2018/004
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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