UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023137 |
|---|---|
| Receipt number | R000026663 |
| Scientific Title | Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2016/07/12 17:53:06 |
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Basic information
Public title
Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing
Acronym
Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing
Scientific Title
Change of the bacterial count of the mouth guard in the oral cavity by the rehydration at the mouth guard wearing
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Masayo Yasuda |
Organization
Tokyo Medical and Dental University
Dental Hospital
Division name
Oral Health Care Clinic
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-4649
yasuda.ocsh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Yasuda |
Organization
Tokyo Medical and Dental University Dental Hospital
Division name
Oral Health Care Clinic
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL
03-5803-4649
Homepage URL
yasuda.ocsh@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
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 | 07 | Month | 12 | 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
Date of protocol fixation
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026663
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