UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the new rehabilitation method for jaw deformity patients.
Title of the study (Brief title)	Development of the new rehabilitation method.
Region	Japan

Condition
Condition	Jaw deformity
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of the new rehabilitation method for jaw deformity patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Activity index
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Training group
Interventions/Control_2	Non-training group
Interventions/Control_3	Normal occlusion group
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	10 years-old <=
Age-upper limit	39 years-old >
Gender	Male and Female
Key inclusion criteria	Training group : 50 patients (forward intervention study) who treat the cause of the diagnosis of the chin transformation symptom, surgical correction in Tokushima university hospital by March, 2020 from current study approval day. Non-training group : Orthodontic clinic patient 50 (backward investigation) surgical from January, 2011 to August, 2016 in Tokushima univercity hospital of the diagnosis of the chin transformation symptom whom I treated. Normal occlusion group : Among trust students performing a bedside teaching in this school student, staff and senior Popes, it is 50 individual normal occlusion people.
Key exclusion criteria	Training group, non-training group 1 Chin transformation symptom patient due to inborn character abnormality 2 The patient who has a symptom to temporomandibular joint Normal occlusion group 1 It is a person with the disharmony for the relations between the chin 2 Person having the prosthesis that cuspid, molar tooth relations coat crowding, tooth missing, cusp in other than I grade and top and bottom dentition 3 It is a person with the experience of the correction treatment in the past
Target sample size	150

Research contact person
Name of lead principal investigator	Eiji Tanaka
Organization	Tokushima univercity
Division name	Department of Orthodontics and dentofacial orthopedics, institute of biomedical science
Address	2-50-1 Kuramoto, Tokushima 770-8503, Japan
TEL	088-631-3111
Email	eiji46y@gmail.com

Public contact
Name of contact person	Misako Tano
Organization	Tokushima univercity
Division name	Accounting and Procurement Division
Address	2-50-1 kuramoto, Tokushima 770-8503, Japan
TEL	088-631-3111
Homepage URL
Email	tano.misako@tokushima-u.ac.jp

Sponsor
Institute	Tokushima univercity
Institute
Department

Funding Source
Organization	Tokushima univercity
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 23 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 30 Day
Anticipated trial start date	2016 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 23 Day
Last modified on	2016 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028687