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UMIN-CTR 臨床試験登録情報の閲覧 |
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 UMIN-CTR ホーム |
用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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| 利用者名： | UMIN ID： |
| 試験進捗状況 | 参加者募集終了‐試験継続中/No longer recruiting |
| 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 | 2020/12/08 |
| 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
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| 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
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| 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
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| 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
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| 試験実施地域/Region |
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| 対象疾患/Condition | |||
| 対象疾患名/Condition | Temporomandibular Disorder | ||
| 疾患区分1/Classification by specialty |
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| 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 on the intensity of pain and Maximum mouth opening in patients with TMD for 3 months To determine the effects of education for self-care, reassurance, 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, Muscle Energy technique + Occlusal splint therapy and Education for self-care, reassurance, and counselling (control group) with each other on the intensity of pain and maximum mouth opening in patients with TMD |
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| 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 |
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| 介入1/Interventions/Control_1 | Muscle Energy Technique(20 min session for three days a week for four weeks) + Education for self care, reassurance and counselling
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| 介入2/Interventions/Control_2 | Occlusal splint therapy + Education for self care, reassurance and counselling for three months
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| 介入3/Interventions/Control_3 | Muscle energy technique(20 min session for three days a week for four weeks) + Occlusal splint therapy (for three months) in addition to education for self care reassurance and counselling
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| 介入4/Interventions/Control_4 | Education for self care, reassurance and counselling for one month
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| 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 |
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| 年齢（上限）/Age-upper limit |
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| 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
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| 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
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| 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 |
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| 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 |
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| 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） |
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| 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） |
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| 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 & 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 |
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| 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 |
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| 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 | 参加者募集終了‐試験継続中/No longer recruiting | |||||||
| プロトコル確定日/Date of protocol fixation |
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| 倫理委員会による承認日/Date of IRB |
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| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| フォロー終了(予定)日/Last follow-up date |
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| 入力終了(予定)日/Date of closure to data entry | ||||||||
| データ固定（予定）日/Date trial data considered complete | ||||||||
| 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 |
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| 最終更新日/Last modified on |
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| 閲覧ページへのリンク/Link to view the page | |
| URL(日本語) | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048708 |
| URL(英語) | https://upload.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 |
