Clinical trial NCT04064099: Speech Adaptation When Using Mouthguards
Official title: Speech Adaptation When Using Mouthguards
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rugby
Keywords: dental trauma
rugby
mouthguard
speech
contact sports
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre- and post- design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men aged between 18 and 35;
2. Actively playing rugby;
3. Currently playing in Malaysia Rugby Union;
4. Native speakers of Malay (national language), with the ability to read and write in Malay fluently; and
5. Without any history of either speech or hearing impairment.

Exclusion Criteria:

1. Retired players;
2. National players who did not play rugby within the last six months of the recruitment date; and
3. Players with cleft lip and/or cleft palate; and
4. Players with any history of either speech or hearing impairment.

Primary outcomes:
measure: Change of speech performance over a six-month period
timeFrame: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
Secondary outcomes:
measure: Change of self-assessment of oral impairments over a six-month period
timeFrame: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
Other outcomes:
measure: Change of self-reported compliance of mouthguard use over a six-month period
timeFrame: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
measure: Incidence of dental trauma over a six-month period
timeFrame: Six months, ie. from baseline (T0) to six-month (T3).
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia
Study officials:
affiliation: National University of Malaysia
name: Amy Liew
role: PRINCIPAL_INVESTIGATOR
References: