Skip to main content
OpenTrials
Completed

NCT Number: NCT04064099

Speech Adaptation When Using Mouthguards

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rugby Behavior Communication Speech Verbal Behavior

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Custom-fitted sports mouthguard

Device

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.

Primary outcomes

  1. Change of speech performance over a six-month period

    Time frame: 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.

Secondary outcomes

  1. Change of self-assessment of oral impairments over a six-month period

    Time frame: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use

    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.

Other outcomes

  1. Change of self-reported compliance of mouthguard use over a six-month period

    Time frame: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use

    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.

  2. Incidence of dental trauma over a six-month period

    Time frame: Six months, ie. from baseline (T0) to six-month (T3).

    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.

Sponsors and collaborators

Lead sponsor

Amy Liew

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2019
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.