UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002711 |
|---|---|
| Receipt number | R000003293 |
| Scientific Title | Randamized trial to evaluate the effects of splint therapy for temporomandibular disorders. |
| Date of disclosure of the study information | 2009/11/27 |
| Last modified on | 2016/05/24 15:21:29 |
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Basic information
Public title
Randamized trial to evaluate the effects of splint therapy for temporomandibular disorders.
Acronym
Effects of the splint therapy for TMD.
Scientific Title
Randamized trial to evaluate the effects of splint therapy for temporomandibular disorders.
Scientific Title:Acronym
Effects of the splint therapy for TMD.
Region
| Japan |
Condition
Condition
Temporomandibular-disorders
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effectiveness of the splint therapy for TMD treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Five time evaluation are done after the insertion of the splint. Recording out come are the mouth opeing distance(mm),the pain and TMJ noize with NRS(numerical rating scale)
Key secondary outcomes
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sprint using
Jaw exercise
habit-control
educational guidance
Evaluation of every 2weeks for 12 weeks
Interventions/Control_2
Jaw exercise
habit-control
educational guidance
Evaluation of every 2weeks for 12 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
TMD patients having head-neck &TMJ pain, or TMJ noize, or Jaw-opening limitation.
Key exclusion criteria
Patients rerationg to psychogenic problme. Patients didn't accepted to be participant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nagata |
Organization
The Nippon Dental university, Niigata hospital
Division name
Comprehensive Dental Care
Zip code
Address
1-8 hamaura-cho, Niigata-city,Niigata-prefecture
TEL
025-267-1500
nagata@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nagata |
Organization
The Nippon Dental university, Niigata hospital
Division name
TMD clinic
Zip code
Address
1-8 hamaura-cho, Niigata-city,Niigata-prefecture
TEL
025-267-1500
Homepage URL
nagata@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental university, Niigata hospital
Institute
Department
Personal name
Funding Source
Organization
The Nippon Dental university, Niigata hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nothing
Name of secondary funder(s)
Nothing
IRB Contact (For public release)
Organization
Address
Tel
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
日本歯科大学新潟病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/joor.12332/full
Number of participants that the trial has enrolled
Results
All three parameters significantly decreased over time in both groups. However, there were no significant differences between the two treatment groups in the total comparison or subgroup analyses; an exception was the group with degenerative joint disease. No significant difference between the NS and NS+S treatment approaches was revealed in this study.
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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 05 | Day |
Last modified on
| 2016 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
