UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028526 |
|---|---|
| Receipt number | R000032647 |
| Scientific Title | Study on the effect of newly developed ionic oral cleaning tools |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2017/08/03 18:50:16 |
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Basic information
Public title
Study on the effect of newly developed ionic oral cleaning tools
Acronym
Study on the effect of newly developed ionic oral cleaning tools
Scientific Title
Study on the effect of newly developed ionic oral cleaning tools
Scientific Title:Acronym
Study on the effect of newly developed ionic oral cleaning tools
Region
| Japan |
Condition
Condition
periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A double-blind comparative control of a healthy subject and a patient suffering from periodontitis is performed on a newly developed ionic oral cleaning tools expected to reduce the adsorption power of the tooth surface of plaque by negative ions, the effect of removing the plus consider.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
PPD (Pocket Probing Depth), BOP (Bleeding On Probing), Rustogi Modification method of Navy Plaque Index, breath measurement, questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ionic toothbrush
Interventions/Control_2
ionic electric toothbrush
Interventions/Control_3
toothbrush
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
| 25 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
There are more than 20 teeth left at present
Do not suffer from periodontal disease
Periodontal therapy is in the maintenance phase
Key exclusion criteria
Those who did not agree to participate in the research
Person who is difficult to self-determination
There is no serious systemic illness
Not during pregnancy or lactation
Acute symptoms of periodontal disease are observed
Not taking antimicrobial medicine within 3 months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Mizutani |
Organization
Tokyo Medical and Dental University
Division name
Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL
03-5803-5488
mizuperi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeaki Sudo |
Organization
Tokyo Medical and Dental University
Division name
Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL
03-5803-5488
Homepage URL
t-sudo.peri@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
Self funding
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
東京医科歯科大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | 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
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032647
