UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033066
Receipt number R000037698
Scientific Title Study on effect of mouthguard cleaning solution.
Date of disclosure of the study information 2018/06/20
Last modified on 2021/06/29 07:33:38

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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