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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035260
Receipt No. R000040171
Scientific Title Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Date of disclosure of the study information 2018/12/17
Last modified on 2018/12/14

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Basic information
Public title Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Acronym Jaw opening exercise for TMD pain
Scientific Title Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Scientific Title:Acronym Jaw opening exercise for TMD pain
Region
Japan

Condition
Condition temporomandibular disorders
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine optimal jaw opening exercise for pain attributed temporomandibular disorders.In this study, it is clarified which is effective jaw exercise with or without pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the limitation of daily life due to TMD
(first visit and after 2w, 4w, 8w)
Key secondary outcomes mouth opening range
pain intensity
(first visit and after 2w, 4w, 8w)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 mouth opening execise with pain
Interventions/Control_2 mouth opening execise without pain
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who are classified with at least myalgia or arthralgia by the diagnostic criteria for temporomandibular disorder (DCTMD)
2.Patients whose symptom started more than a month ago and whose symptoms are not changing or becoming worse
3.Patients who cannot open their mouth over 40mm without pain and feel pain that scores over 30mm on a visual analog scale (VAS)
Key exclusion criteria 1.Patients who was classified as disc displacement without reduction by DCTMD
2.Patients who has received surgical operation on their temporomandibular joint or masticatory muscles
3.Patients who took analgesic drugs within the previous three days
4.Patients who have received any treatment for current pain
5.Patients who are diagnosed as degenerative joint disorder(erosion, atrophy, osteophyte)based on panoramic X-ray examination
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Nishiyama
Organization Tokyo Medical and Dental University
Division name Orofacial Pain Management
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5713
Email anishi.tmj@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Nishiyama
Organization Tokyo Medical and Dental University
Division name Orofacial Pain Management
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5713
Homepage URL
Email anishi.tmj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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