UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020987 |
|---|---|
| Receipt number | R000024228 |
| Scientific Title | Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2018/09/18 09:36:08 |
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Basic information
Public title
Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy
Acronym
Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy
Scientific Title
Effect of newly developed mouthguard for tooth protection during tracheal intubation and endoscopy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Suzuki Tetsuya |
Organization
Tokyo medical and dental university
Division name
Oral Prosthetic Engineering
Zip code
Address
5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL
03-5803-5780
suzuki.peoe@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suzuki Tetsuya |
Organization
Tokyo medical and dental university
Division name
Oral Prosthetic Engineering
Zip code
Address
5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL
03-5803-5780
Homepage URL
suzuki.peoe@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university, Oral Prosthetic Engineering
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024228
