Speech Adaptation When Using Mouthguards
19 de agosto de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
35
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Kuala Lumpur, Malasia, 50300
- Universiti Kebangsaan Malaysia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 35 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of speech performance over a six-month period
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of self-assessment of oral impairments over a six-month period
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of self-reported compliance of mouthguard use over a six-month period
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Amy Liew, National University of Malaysia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de octubre de 2017
Finalización primaria (Actual)
25 de enero de 2019
Finalización del estudio (Actual)
8 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
7 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2019
Publicado por primera vez (Actual)
21 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UKMPPI/111/8/JEP-2017-439
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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