UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing
Title of the study (Brief title)	Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing
Region	Japan

Condition
Condition	Dental caries
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the current study, when we exercise to examine the caries prophylaxis to the person who puts on a mouth guard, and plays sports while attaching a mouth guard, and taking in sports drinks or mineral water, we weigh it how an attachment bacterial count of in saliva and the mouth guard internal surface changes.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We obtain the front tooth of the mouth guard and bacteria of molar tooth each using a sterile cotton swab after daily conservation with an exclusive case after taking off a mouth guard and suspend bacteria in entering sterile saline tube of 150microliter and disseminate it to the MS agar which did 25microliter of those division into four, MSB culture media and, for 5-6 days, culture it at 37 degrees Celsius.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The exercise testing in the experiment performs aerobic exercise 30 minutes at the level that an aim pulse level becomes 80% of best pulses after the warm-up of approximately 15 minutes using a bicycle ergometer (exercise bike ai: a product made in combination wellness Corporation). We can perform the aerobic exercise that computerizes the information from the high sensitive pulse sensor which we attached to the earlobe in real time, and controls the load of the pedal automatically, and accepted a setting pulse level in this instrument. The mineral water takes in 150 ml per once three times every 10 minutes. In addition, the intake performs in the state that took off a mouth guard and include it before exercise initiation and perform four times in total. We conduct sampling (approximately 1mL) of the rest saliva to a sterile test tube after the end if before initiation of the exercise testing.
Interventions/Control_2	The exercise testing in the experiment performs aerobic exercise 30 minutes at the level that an aim pulse level becomes 80% of best pulses after the warm-up of approximately 15 minutes using a bicycle ergometer (exercise bike ai: a product made in combination wellness Corporation). We can perform the aerobic exercise that computerizes the information from the high sensitive pulse sensor which we attached to the earlobe in real time, and controls the load of the pedal automatically, and accepted a setting pulse level in this instrument. The sports drinks take in 150 ml per once three times every 10 minutes. In addition, the intake performs in the state that took off a mouth guard and include it before exercise initiation and perform four times in total. We conduct sampling (approximately 1mL) of the rest saliva to a sterile test tube after the end if before initiation of the exercise testing.
Interventions/Control_3	We take in 150 ml per once with mineral water with locus three times every 10 minutes. In addition, the intake performs in the state that took off a mouth guard and performs four times in total. We conduct sampling (approximately 1mL) of the rest saliva to a sterile test tube before initiation 45 minutes later
Interventions/Control_4	We take in 150 ml per once in sports drinks with locus three times every 10 minutes. In addition, the intake performs in the state that took off a mouth guard and performs four times in total. We conduct sampling (approximately 1mL) of the rest saliva to a sterile test tube before initiation 45 minutes later
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	The person who has no physical or mental disabilities
Key exclusion criteria	The person who takes antibiotics within three months Smokers The person who has a serious systemic disease
Target sample size	40

Research contact person
Name of lead principal investigator	Masayo Yasuda
Organization	Tokyo Medical and Dental University Dental Hospital
Division name	Oral Health Care Clinic
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-4649
Email	yasuda.ocsh@tmd.ac.jp

Public contact
Name of contact person	Masayo Yasuda
Organization	Tokyo Medical and Dental University Dental Hospital
Division name	Oral Health Care Clinic
Address	1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL	03-5803-4649
Homepage URL
Email	yasuda.ocsh@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Medical and Dental University
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 07 Month 12 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 06 Day
Anticipated trial start date	2016 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 07 Month 12 Day
Last modified on	2016 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026663