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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033066
Receipt No. R000037698
Scientific Title Study on effect of mouthguard cleaning solution.
Date of disclosure of the study information 2018/06/20
Last modified on 2019/06/24

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Basic information
Public title Study on effect of mouthguard cleaning solution.
Acronym Study on effect of mouthguard cleaning solution.
Scientific Title Study on effect of mouthguard cleaning solution.
Scientific Title:Acronym Study on effect of mouthguard cleaning solution.
Region
Japan

Condition
Condition sports athlete
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this sudy examine cleaning and color changing of mouthguards by cleaning solution.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mouthguard color changing after 2 months using.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Group of using mouthguard cleaning solution
Interventions/Control_2 Group of not using mouthguard cleaning solution
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
22 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria sports athlete who usese mouthguard
Key exclusion criteria infancy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Suzuki
Organization Nihon University School of Dentistry at Matsudo
Division name Division of Oral Function and Rehabilitation, Department of Oral Health Science
Zip code 271-8587
Address 2-870-1 Sakaecho-Nishi, Matsudo city
TEL 047-360-9641
Email suzuki.hirshi91@nihon-u.ac.hp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Tamatsu
Organization Nihon University School of Dentistry at Matsudo
Division name Research Affairs Section
Zip code 271-8587
Address 2-870-1 Sakaecho-Nishi, Matsudo city
TEL 047-360-9274
Homepage URL
Email tamatsu.masaki@nihon-u.ac.jp

Sponsor
Institute Division of Oral Function and Rehabilitation, Department of Oral Health Science
Nihon University School of Dentistry at Matsudo
Institute
Department

Funding Source
Organization Nihon University School of Dentistry at Matsudo
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 Nihon University School of Dentistry at Matsudo
Address 2-870-1 Sakaecho-Nishi Marsudo-city
Tel 047-360-9642
Email suzuki.hiroshi91@nihon-u.acjp

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 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 47
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 Completed
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
2018 Year 09 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 10 Day
Last follow-up date
2019 Year 05 Month 05 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 11 Month 10 Day
Date analysis concluded
2018 Year 12 Month 13 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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