Speech Adaptation When Using Mouthguards

NCT04064099 | Completed

• 1 other identifier: UKMPPI/111/8/JEP-2017-439
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Rugby

Keywords

dental trauma; rugby; mouthguard; speech; contact sports

Outcome Measures

Primary Outcomes (1)

• Change of speech performance over a six-month period

  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.

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

Secondary Outcomes (1)

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

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

Other Outcomes (2)

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

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

• Incidence of dental trauma over a six-month period

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

Study Arms (1)

Rugby Players

EXPERIMENTAL

Rugby player will be given custom-fitted mouthguards to be worn for 6-month

Device: Custom-fitted sports mouthguard

Interventions

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.

Rugby Players

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amy Liew: lead

Study Sites (1)

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (1)

• Mat Zainal MK, Liew AKC, Abdullah D, Soo E, Abdul Hamid B, Ramlee RAM. Changes in oral functions and speech when using custom-fitted mouthguards: An uncontrolled before-and-after study. Dent Traumatol. 2024 Aug;40(4):460-469. doi: 10.1111/edt.12939. Epub 2024 Mar 8.

  PMID: 38459669 DERIVED

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior

Study Officials

• Amy Liew

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Single group pre- and post- design

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 21, 2019
• Study Start: October 4, 2017
• Primary Completion: January 25, 2019
• Study Completion: March 8, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)