Speech Adaptation When Using Mouthguards
19 août 2019 mis à jour par: Amy Liew
The aim of this study is to evaluate the speech performance of professional rugby players when using custom-fitted mouthguards over a six-month period.
Consented players will be given custom-fitted mouthguards and they will be instructed on the use and care of the mouthguards.
At five time points: baseline, immediately following mouthguard use (T1), one-week after- (T2), one-month after- (T3) and six-month after use (T4), participants are required to pronounce four selected phonemes.
Three recordings will be made for each phoneme.
Spectrspectrographic analysis will be performed to assess the acoustic characteristics of the sound.
Concurrently, they will be asked to fill up a questionnaire on self-assessment of oral impairments.
Throughout the six-month period, the compliance of wearing mouthguards and the occurrence of dental trauma during training will be monitored on-site by the researcher or if not available, an assigned coach.
A 24-hour helpline will be provided as a surveillance tool to monitor problems with mouthguards and dental trauma.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Rugby exposes players to increased risk of dental trauma.
Thus, mouthguard use is recommended to provide a resilient surface for shock absorption and impact dissipation.
However, some discontinued using mouthguard complaint that general discomfort and speech disturbance are the main barriers to their compliance.
The nuisance is largely due to their use of poorly-fitted stock or boil-and-bite mouthguards.
Therefore, the primary objective of this study is to evaluate speech adaptations when using custom-fitted mouthguards.
The secondary objective is to assess the incidence of dental trauma within the six-month duration of mouthguard use.
A prospective study will be carried out at the National Sports Institute.
During the first day (T0), a workshop on the prevention and management of dental trauma will be carried out.
Then, dental examination, dental impression, and recording of baseline speech performance will be performed.
During the second visit (T1), mouthguards delivery, self-assessment of oral impairments, and speech recording will be carried out.
After 6-months of monitoring (T2), all participants will be called again to fill in the self-assessment form and final speech performance will be recorded.
Data analysis will be carried out to evaluate the self-assessment of speech performance and digital sonography of speech recordings over time.
Also, the incidence of dental trauma will be reported.
Type d'étude
Interventionnel
Inscription (Réel)
35
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Kuala Lumpur, Malaisie, 50300
- Universiti Kebangsaan Malaysia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 35 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Men aged between 18 and 35;
- Actively playing rugby;
- Currently playing in Malaysia Rugby Union;
- Native speakers of Malay (national language), with the ability to read and write in Malay fluently; and
- Without any history of either speech or hearing impairment.
Exclusion Criteria:
- Retired players;
- National players who did not play rugby within the last six months of the recruitment date; and
- Players with cleft lip and/or cleft palate; and
- Players with any history of either speech or hearing impairment.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Rugby Players
Rugby player will be given custom-fitted mouthguards to be worn for 6-month
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Pressure dual laminated technique will be used to fabricate the mouthguards.
Ethylene-vinyl acetate (EVA) thermoplastic sheets of 3 mm in thickness with 125 mm diameter (Dentsply International Raintree Essix, Court East Sarasota, USA) will be used.
Two 3 mm sheets pressure-laminated together should form an even thickness of 4 mm mouthguard.
The design of the mouthguards takes into consideration of the following limits: (i) the labial borders of the mouthguard were extended to within 2 mm of the vestibular reflection, (ii) the palatal margins were trimmed to the cervical area of the palatal surface of the upper teeth, (iii) enclosing the maxillary teeth to the distal surface of the first molars.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of speech performance over a six-month period
Délai: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
|
Participants will be asked to pronounce the words (paku for phoneme /p/, bola for phoneme /b/, tatu for phoneme /t/, and dadu for phoneme /d/) one by one when it was shown on the computer screen.
Three recordings were obtained for each word.
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Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of self-assessment of oral impairments over a six-month period
Délai: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
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A questionnaire with a list of oral impairments and five-point Likert scale will be used.
The scale name is "Specific problem when using the mouthguard given".
Participants will be asked to rate how often they experience the following problems: (i) loose mouthguard, (ii) difficulty speaking, (iii) lisping, (iv) nausea, (v) breathing difficulty, (vi) bulkiness in mouth, (vii) dryness of mouth, (viii) bad breath, (ix) ulcers/sores in mouth, and (x) redness in mouth.
The five-point Likert scales have these values: 1=never, 2=rarely, 3=sometimes, 4=often, 5=always.
Median score for each question will be reported.
Higher values represent worse outcomes.
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Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change of self-reported compliance of mouthguard use over a six-month period
Délai: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
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A questionnaire of compliance and five-point Likert scale will be used.
The scale name is "Frequency of wearing the mouthguard given".
There are two questions: (i) How often do you use the mouthguard during training?, and (ii) How often do you use the mouthguard during competitions?
The five-point Likert scales have these values: 1=never, 2=rarely, 3=sometimes, 4=often, 5=always.
The median score for each question will be reported.
Higher values represent better compliance.
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Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
|
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Incidence of dental trauma over a six-month period
Délai: Six months, ie. from baseline (T0) to six-month (T3).
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On-site monitoring and 24-hour helpline will be carried out to identify the incidence of dental trauma related to rugby playing.
The type of data is count data.
The total number of occurrence will be divided by the six months to obtain the incidence rate.
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Six months, ie. from baseline (T0) to six-month (T3).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Amy Liew, National University of Malaysia
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 octobre 2017
Achèvement primaire (Réel)
25 janvier 2019
Achèvement de l'étude (Réel)
8 mars 2019
Dates d'inscription aux études
Première soumission
7 août 2019
Première soumission répondant aux critères de contrôle qualité
19 août 2019
Première publication (Réel)
21 août 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- UKMPPI/111/8/JEP-2017-439
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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