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利用者名
UMIN ID

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042685
受付番号 R000048708
科学的試験名
一般公開日(本登録希望日) 2020/12/08
最終更新日 2021/06/30

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
一般向け試験名略称/Acronym
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
科学的試験名/Scientific Title
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
科学的試験名略称/Scientific Title:Acronym
Comparative evaluation for the effects of occlusal splint therapy and Muscle Energy Technique(MET) in the management of temporomandibular disorders(TMD): A Randomized Controlled Clinical Trial
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Temporomandibular Disorder
疾患区分1/Classification by specialty
歯学/Dental medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To determine the effects of muscle energy technique on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of Occlusal splint Therapy on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of Muscle Energy Technique + Occlusal splint therapy (Combined treatment) on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To determine the effects of education for self-managemen, and counselling on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months
To compare the effects of Muscle Energy Technique, Occlusal splint Therapy, Combined treatment and Education for self-management and counselling (control group)on the intensity of pain and maximum mouth opening in patients with TMD
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Intensity of pain on visual analogue scale at baseline, after 1 week, after 2 weeks, after 1 month and after 3 months
副次アウトカム評価項目/Key secondary outcomes
Maximum mouth opening at baseline, after 1 week, after 2 weeks, after 1 month and after 3 months

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 4
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医療器具・機器/Device,equipment 行動・習慣/Behavior,custom
手技/Maneuver その他/Other
介入1/Interventions/Control_1
Muscle Energy Technique(30 min session for three days a week for four weeks) + Education for self-management, and counselling
介入2/Interventions/Control_2
Occlusal splint therapy + Education for self-management and counselling for three months
介入3/Interventions/Control_3
Muscle energy technique(30 min session for three days a week for four weeks) + Occlusal splint therapy (for three months) in addition to education for self-managementand counselling
介入4/Interventions/Control_4
Education for self-management and counselling alone for one month
介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old より上/<
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1)Pain in TMJ, Muscles of mastication or both, 2)Reduced mouth opening including the verticle overlap of <40mm,3) Symptoms present for> 4 weeks
除外基準/Key exclusion criteria
1) patients under treatment of analgesics,muscle relaxants and anti depressants,2)Abscence of upper and/or lower central incisor,3)Presence of complete or removable partial prostheses with distal extension,4)patients who received orthodontic treatment in the past,5)patients with oral submucous fibrosis,6)Patients who were unable to attend the Hospital for the Prescribed treatment period,7)The Patient who insisted on for a specific treatment (e.g. occlusal adjustments, medication),8)Patients with Malignant tumours of the face and jaw,9)History of fracture or surgery of jaw or TMJ,10)Patients who had received any form of treatment for TMD in past,


目標参加者数/Target sample size 160

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Dr Hardik
ミドルネーム Keshubhai
Ram
所属組織/Organization
Ahmedabad Dental College & Hospital
所属部署/Division name
Dept. of Prosthodontics
郵便番号/Zip code 382115
住所/Address
Bhadaj-Ranchhodpura road,Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar, 382115
電話/TEL 9879779994
Email/Email drhkram@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Dr Hardik
ミドルネーム Keshubhai
Ram
組織名/Organization
Ahmedabad Dental College & hospital
部署名/Division name
Dept. Of Prosthodontics
郵便番号/Zip code 362220
住所/Address
P.M Park, Barsana Society, Mangarol Road, Keshod-362220
電話/TEL 9879779994
試験のホームページURL/Homepage URL
Email/Email drhkram@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Ahmedabad Dental College & Hospital
Dept. Of Prosthodontics
Bhadaj-Ranchhodpura road, Santej, Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 self
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
Indian

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
self
その他の研究費提供組織/Name of secondary funder(s)
self

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Ahmedabad Dental College & Hospital
住所/Address
Bhadaj-Ranchhodpura road, Santej, Nr. Science city, Ta:- Kalol, Dist:- Gandhinagar
電話/Tel 02764-260447
Email/Email info@adc.org.in

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Ahmedabad Dental College & Hospital, AMC Dental College & Hospital, Siddhpur Dental College & Hospital

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 12 08

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 160
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Covid -19
最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 12 02
倫理委員会による承認日/Date of IRB
2015 12 15
登録・組入れ開始(予定)日/Anticipated trial start date
2015 12 28
フォロー終了(予定)日/Last follow-up date
2020 03 12
入力終了(予定)日/Date of closure to data entry
2020 03 12
データ固定(予定)日/Date trial data considered complete
2020 03 12
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 12 08
最終更新日/Last modified on
2021 06 30


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048708
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048708

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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