UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033900 |
|---|---|
| Receipt number | 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 15:28:14 |
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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
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
shori@ngt.ndu.ac.jp
Sponsor or person
Institute
Niigata Hospital, The Nippon Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038452
