Speech Adaptation When Using Mouthguards
2019年8月19日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
35
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Kuala Lumpur、マレーシア、50300
- Universiti Kebangsaan Malaysia
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～35年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Rugby Players
Rugby player will be given custom-fitted mouthguards to be worn for 6-month
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of speech performance over a six-month period
時間枠：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.
|
Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of self-assessment of oral impairments over a six-month period
時間枠：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.
|
Baseline (T0), immediately after (T1), one-week after (T2), one-month after (T3) and six-month after (T4) mouthguard use
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change of self-reported compliance of mouthguard use over a six-month period
時間枠：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.
|
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
時間枠：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.
|
Six months, ie. from baseline (T0) to six-month (T3).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Amy Liew、National University of Malaysia
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月4日
一次修了 (実際)
2019年1月25日
研究の完了 (実際)
2019年3月8日
試験登録日
最初に提出
2019年8月7日
QC基準を満たした最初の提出物
2019年8月19日
最初の投稿 (実際)
2019年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月21日
QC基準を満たした最後の更新が送信されました
2019年8月19日
最終確認日
2019年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。