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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021673
Receipt No. 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

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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
Email 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
Email tomomatsu.mfs@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024993

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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