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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033900
Receipt No. R000038452
Scientific Title Effects of bruxism relaxation training in patients with temporomandibular disorders: A randomized controlled trial
Date of disclosure of the study information 2018/09/01
Last modified on 2019/07/22

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Basic information
Public title Effects of bruxism relaxation training in patients with temporomandibular disorders: A randomized controlled trial
Acronym Relaxation training for bruxism.
Scientific Title Effects of bruxism relaxation training in patients with temporomandibular disorders: A randomized controlled trial
Scientific Title:Acronym Relaxation training for bruxism.
Region
Japan

Condition
Condition Temporomandibular disorder
Bruxism
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of relaxation exercise in patients with temporomandibular disorders through a randomized controlled trial
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Clinical signs and symptoms: evaluation of temporomandibular joint or muscle pain using a numerical rating scale (NRS) and evaluation of subjective bruxism
Key secondary outcomes Masticatory muscle activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Mandibular exercise and education for temporomandibular disorders
Interventions/Control_2 Mandibular exercise and education for temporomandibular disorders plus masticatory muscle stretches
Interventions/Control_3 Mandibular exercise and education for temporomandibular disorders, plus masticatory muscle stretches and non-contact training to keep the teeth apart and unclench them
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

Not applicable
Gender Male and Female
Key inclusion criteria Presence of temporomandibular disorder accompanied by myalgia or arthralgia as per the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Key exclusion criteria 1)Presence of temporomandibular disorders with a diagnosis of only intra-articular joint disorders
2)Presence of any mental or physical difficulties that might interfere with treatment
3)Inability to visit our clinic during the specific 4-5week period
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Kauhiro
Middle name
Last name Nagata
Organization Temporomandibular Disorders and Bruxism Clinic
Division name Niigata Hospital, The Nippon Dental University
Zip code 9518580
Address 1-8 Hamaura-cho, Niigata City, Niigata, 951-8580, Japan
TEL 025-267-1500
Email nagata@ngt.ndu.ac.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Hori
Organization Temporomandibular Disorders and Bruxism Clinic
Division name Niigata Hospital, The Nippon Dental University
Zip code 9518580
Address 1-8 Hamaura-cho, Niigata City, Niigata, 951-8580, Japan
TEL 025-267-1500
Homepage URL
Email shori@ngt.ndu.ac.jp

Sponsor
Institute Niigata Hospital, The Nippon Dental University
Institute
Department

Funding Source
Organization Niigata Hospital, The Nippon 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 Ethical Review Board of Nippon Dental University Niigata Hospital
Address 1-8 Hamaura_chou Niigata_city Niigata JAPAN
Tel 025-267-1500
Email waka@ngt.ndu.ac.jp

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 09 Month 01 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
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 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 08 Month 26 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038452

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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