UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012504 |
|---|---|
| Receipt number | R000010490 |
| Scientific Title | Development and evaluation of a new oral care method to elederly and compromised patients with antimicrobial photodynamic therapy |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2013/12/06 10:09:34 |
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Basic information
Public title
Development and evaluation of a new oral care method to elederly and compromised patients with antimicrobial photodynamic therapy
Acronym
Development and evaluation of a new oral care method with antimicrobial photodynamic therapy
Scientific Title
Development and evaluation of a new oral care method to elederly and compromised patients with antimicrobial photodynamic therapy
Scientific Title:Acronym
Development and evaluation of a new oral care method with antimicrobial photodynamic therapy
Region
| Japan |
Condition
Condition
oral disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To use the methods of antimicrobial photodynamic therapy as oral care to elderly or compromised patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
1. the ratio of the all surface area to plaque covered area
2. the number of collected dental plaque
3. the number of bacteria in gingival cerucus fluid
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
term: 4 days
dose: about 0.5mL Toluidine blue water solution
frequency: twice a day
Interventions/Control_2
control group teeth won't been brushed in the term
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. dentist
Key exclusion criteria
the person who don't have premolars
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maruoka Yutaka |
Organization
National Center for Global Health and Medicine
Division name
Division of Oral and Maxillofacial Surgery
Zip code
Address
1-21-1 Toyama Shinjuku-ku Tokyo
TEL
03-3202-7181
ymaruoka@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichinose-Tsuno Akiko |
Organization
National Center for Global Health and Medicine
Division name
Division of Oral and Maxillofacial Surgery
Zip code
Address
1-21-1 Toyama Shinjuku-ku Tokyo
TEL
03-3202-7181
Homepage URL
akitsuno@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Other
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
| 2013 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
The title of Ethic inspection "Development and evaluation of a new oral care method to elederly and compromised patients with antimicrobial photodynamic therapy" is defferent from this UMIN registry title.
The application to Ethic Commitie contains two trials; for healthy adults and for patiens. This subject is the part of the trial for healthy adults.
Management information
Registered date
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2013 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010490
