UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect and Safety of the sports mouthguard
Title of the study (Brief title)	The Effect of the mouthguard
Region	Japan

Condition
Condition	Trauma of sports
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the effect and safety of the sports mouthguard
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The questionnaire of the sports performance and feeling mouthgurd, fitting, fitness test, calculation
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Sports mouthguad
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	The people in the club or circle of sports
Key exclusion criteria	The people that can't evaluate the effect and wear the mouthgurd.
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshizo Matsuka
Organization	The University of Tokushima Graduate School
Division name	Department of Fixed Prosthodontics
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima, Japan
TEL	088-633-7350
Email	matsuka@tokushima-u.ac.jp

Public contact
Name of contact person	Yoshitaka Suzuki
Organization	Tokushima University Hospital
Division name	General dentistry
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima, Japan
TEL	088-633-7350
Homepage URL
Email	yosuzuki@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

Funding Source
Organization	Tokushima University Hospital
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	2014 Year 01 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 01 Month 13 Day
Anticipated trial start date	2014 Year 01 Month 14 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

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Publication of results	Unpublished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

Management information
Registered date	2014 Year 01 Month 13 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014999