Speech Adaptation When Using Mouthguards
2019년 8월 19일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
35
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kuala Lumpur, 말레이시아, 50300
- Universiti Kebangsaan Malaysia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of speech performance over a six-month period
기간: Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of self-assessment of oral impairments over a six-month period
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of self-reported compliance of mouthguard use over a six-month period
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Amy Liew, National University of Malaysia
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 10월 4일
기본 완료 (실제)
2019년 1월 25일
연구 완료 (실제)
2019년 3월 8일
연구 등록 날짜
최초 제출
2019년 8월 7일
QC 기준을 충족하는 최초 제출
2019년 8월 19일
처음 게시됨 (실제)
2019년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 8월 19일
마지막으로 확인됨
2019년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .