UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010437 |
|---|---|
| Receipt number | 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 15:06:26 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012170
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