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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002711
Receipt No. 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

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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
Email 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
Email nagata@ngt.ndu.ac.jp

Sponsor
Institute The Nippon Dental university, Niigata hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003293

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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