UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy
Title of the study (Brief title)	Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy
Region	Japan

Condition
Condition	Tooth dislocation and fracture
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of fitting with mouthguard
Basic objectives2	Others
Basic objectives -Others	Bite force measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of feeling using visual analogue scale (VAS) method for ten minutes
Key secondary outcomes	Measurement of bite force using bite force device for ten minutes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Insertion of soft type mouthguard for twenty minutes
Interventions/Control_2	Insertion of combination type mouthguard for twenty minutes
Interventions/Control_3	Insertion of hard type mouthguard for twenty minutes
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	18 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	Normal dental arch
Key exclusion criteria	Anormal dental arch
Target sample size	15

Research contact person
Name of lead principal investigator	Suzuki Tetsuya
Organization	Tokyo medical and dental university
Division name	Oral Prosthetic Engineering
Address	5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL	03-5803-5780
Email	suzuki.peoe@tmd.ac.jp

Public contact
Name of contact person	Suzuki Tetsuya
Organization	Tokyo medical and dental university
Division name	Oral Prosthetic Engineering
Address	5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL	03-5803-5780
Homepage URL
Email	suzuki.peoe@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university, Oral Prosthetic Engineering
Institute
Department

Funding Source
Organization	government grant
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 02 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2016 Year 05 Month 01 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete	2016 Year 07 Month 01 Day
Date analysis concluded	2016 Year 08 Month 01 Day

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

Management information
Registered date	2016 Year 02 Month 12 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024228