UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Acoustical and Kinematical study on the pronunciation of the patients with abnormal occlusion
Title of the study (Brief title)	Study on the pronunciation of the patients with abnormal occlusion
Region	Japan

Condition
Condition	maloccluison
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyse the characteristic feature of the pronunciation of the patients with malocclusion
Basic objectives2	Others
Basic objectives -Others	Acoustical analysis on the pronunciation of the patients with malocclusion, Kinematical observation of the movement of sofy tissue surrounding lip of the patients with malocclusion
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	sound spectrum, sono guraph, observation on the 3D movement of soft tissue using motion capture
Key secondary outcomes	classification of malocclusion over jet, over bite

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Additional inspections other than usual inspections for orthodontic treatments.
Interventions/Control_2	Acoustical inspections for the pronuciation of the patients with malocclusion
Interventions/Control_3	Kinematical inspections for the movement of soft tissue surrounding lip of the patients with malocclusion
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with malocclusion
Key exclusion criteria	patients with allergic reaction to the adhesives for plastic ball to the skin.
Target sample size	60

Research contact person
Name of lead principal investigator	Shoichi Suzuki
Organization	graduate school for medical and dental science
Division name	department of maxillofacial orthognathics
Address	1-5-45 yushima bunkyou-ku tokyo
TEL	03-5803-5533
Email	s-suzuki.mort@tmd.ac.jp

Public contact
Name of contact person	Shoichi Suzuki
Organization	graduate school for medical and dental science
Division name	department of maxillofacial orthognathics
Address	1-5-45 yushima bunkyou-ku tokyo
TEL	03-5803-5533
Homepage URL
Email	s-suzuki.mort@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)

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	2018 Year 07 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 30 Day
Anticipated trial start date	2018 Year 07 Month 01 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	2018 Year 05 Month 30 Day
Last modified on	2018 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037405