UMIN-CTR Clinical Trial

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	https://www.quint-j.co.jp/web/JSD/
Publication of results	Published

Result
URL related to results and publications	https://www.quint-j.co.jp/web/JSD/
Number of participants that the trial has enrolled	47
Results	Comparing and examining the change in the color tone of MG due to the use, non-use of the sterilizing component-containing spray, no significant discoloration was found in the MG of the sterilizing component-containing spray using group. Otherwise, the MG of the spray use group not containing CPC showed a brownish discoloration that seemed to be apparently dirty. The CPC cleaning spray showed antibacterial effect on the mouthguard, suggesting the effect of preventing discoloration caused by oral bacteria.
Results date posted	2019 Year 11 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	sports athlete
Participant flow	Rugby athlete
Adverse events	none
Outcome measures	Comparing and examining the change in the color tone of MG
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	2021 Year 06 Month 29 Day

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