UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021673 |
|---|---|
| Receipt number | R000024993 |
| Scientific Title | Randomized controlled trial on the efficacy of prosthetic mandibular advancement in patients with mandibular retrusion. |
| Date of disclosure of the study information | 2016/03/29 |
| Last modified on | 2017/09/29 14:06:23 |
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Basic information
Public title
Randomized controlled trial on the efficacy of prosthetic mandibular advancement in patients with mandibular retrusion.
Acronym
Randomized controlled trial on the efficacy of prosthetic mandibular advancement in patients with mandibular retrusion.
Scientific Title
Randomized controlled trial on the efficacy of prosthetic mandibular advancement in patients with mandibular retrusion.
Scientific Title:Acronym
Randomized controlled trial on the efficacy of prosthetic mandibular advancement in patients with mandibular retrusion.
Region
| Japan |
Condition
Condition
mandibular retrusion
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effecacy of prathetic mandibular advancement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
X-ray, photo
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
use of prothetic mandibular adcancement sprint
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
mandibular retrusion
Key exclusion criteria
under 20 years old.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuto Kurohara |
Organization
Tokyo Medical and Dental University
Division name
Department of Maxillofacial surgery
Zip code
Address
1-5-45 Yushima Bunkyo Tokyo
TEL
03-5803-5500
kuzkuroh.mfs@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NOBUYOSHI TOMOMATSU |
Organization
Tokyo Medical and Dental University
Division name
Department of Maxillofacial surgery
Zip code
Address
1-5-45 Yushima Bunkyo Tokyo
TEL
03-5803-5500
Homepage URL
tomomatsu.mfs@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
東京医科歯科大学歯学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024993
