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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010437
Receipt No. R000012170
Scientific Title Effectiveness of the manipulation technique for temporomandibular disorder (TMD) patients with limited mouth-opening - A randomized controlled trial -
Date of disclosure of the study information 2013/04/30
Last modified on 2019/07/22

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Basic information
Public title Effectiveness of the manipulation technique for temporomandibular disorder (TMD) patients with limited mouth-opening
- A randomized controlled trial -
Acronym Effectiveness of the manipulation technique for TMD
Scientific Title Effectiveness of the manipulation technique for temporomandibular disorder (TMD) patients with limited mouth-opening
- A randomized controlled trial -
Scientific Title:Acronym Effectiveness of the manipulation technique for TMD
Region
Japan

Condition
Condition Temporomandibular disorder (TMD)
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to
determine the clinical effectiveness of the manipulation for temporomandibular disorder patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Evaluation of orofacial pain, tempromandibular joint soud, moth opning limiation. 10weeks assesment ever 2 weeks.
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 considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Standard treatments;education; self-exercise of the jaw; cognitive-behavioral therapy
Interventions/Control_2 Standard treatment plus the manipulation technique for temporomandibular joint. It is applied every 2 weeks from start of the treatment to 10 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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria TMD patients with the mouth opening limiation (less than 35mm )
Key exclusion criteria 1)A patient is not able to attend our clinic in a set period 2-4 weeks.

2)A patient has a mental or physical problem that interfere with the treatment.

3)A patient discontinue the treatment after the first visit.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Nagata
Organization The Nippon Dental University Niigata Hospital
Division name TMD and Bruxism, Comprehensive Dental Care
Zip code 9518580
Address 1-8 Hamaura_chou Niigata_city Niigata JAPAN
TEL 025-267-1500
Email nagata@ngt.ndu.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Nagata
Organization The Nippon Dental University Niigata Hospital
Division name TMD and Bruxism clinic, Comprehensive Dental Care
Zip code 9518580
Address 1-8 Hamaura_chou Niigata_city Niigata JAPAN
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

Other related organizations
Co-sponsor Watanabe dental and oralsurgery clinic, incorporated medical institution
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 日本歯科大学新潟病院 総合診療科 あごの関節外来
医療法人 渡辺歯科口腔外科

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 30 Day

Related information
URL releasing protocol https://www.sciencedirect.com/science/article/pii/S1883195818304420?via%3Dihub
Publication of results Unpublished

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S1883195818304420?via%3Dihub
Number of participants that the trial has enrolled 61
Results
No statistical difference was observed between the two treatment groups except for mouth-opening limitation after treatment at the first visit. Subgroup analyses, stratified according to the pathological type of TMD, indicated a similar trend.
Results date posted
2019 Year 07 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were selected from among patients who were admitted to our Hospital between May 2014 and June 2017. All participants had been diagnosed with TMD with the Diagnostic Criteria for Temporomandibular Disorders axis I. All exhibited mouth-opening limitation, where the maximum self-opening distance between upper and lower middle incisors was less than 35 mm.
Participant flow
Enrollment(n=82) 
Allocation and Randomized(n=66)
RCT analysis(n=31:with manipulation)(n=30:without manipulation)
Subgroupanalysis(n=23:with manipulation)(n=24:without manipulation)
Adverse events
No adverse events to be discussed were identified
Outcome measures
Three TMD signs/symptoms of mouth-opening distance, orofacial pain, and TMJ sounds were recorded for all patients to evaluate treatment efficacy. There were 11 measurement points in the study: baseline, then after treatment at the first visit and every 2 weeks thereafter, from 2 to 18 weeks after baseline.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 06 Month 01 Day
Date of IRB
2003 Year 06 Month 01 Day
Anticipated trial start date
2003 Year 06 Month 01 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
2017 Year 07 Month 01 Day
Date trial data considered complete
2017 Year 07 Month 01 Day
Date analysis concluded
2017 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 07 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=R000012170

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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