UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randamized trial to evaluate the effects of splint therapy for temporomandibular disorders.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kazuhiro Nagata
Organization	The Nippon Dental university, Niigata hospital
Division name	Comprehensive Dental Care
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	Kazuhiro Nagata
Organization	The Nippon Dental university, Niigata hospital
Division name	TMD clinic
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/joor.12332/full
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.
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