UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011530 |
|---|---|
| Receipt number | R000013484 |
| Scientific Title | A Study on the Effects of Cetylpyridinium Chloride Oral Ointment Containing Phosphorylated Pullulan on Oral Microflora and Oral Mucosa |
| Date of disclosure of the study information | 2013/08/20 |
| Last modified on | 2016/12/27 11:24:53 |
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Basic information
Public title
A Study on the Effects of Cetylpyridinium Chloride Oral Ointment Containing Phosphorylated Pullulan on Oral Microflora and Oral Mucosa
Acronym
A Study on the Effects of CPC Oral Ointment Containing Phosphorylated Pullulan
Scientific Title
A Study on the Effects of Cetylpyridinium Chloride Oral Ointment Containing Phosphorylated Pullulan on Oral Microflora and Oral Mucosa
Scientific Title:Acronym
A Study on the Effects of CPC Oral Ointment Containing Phosphorylated Pullulan
Region
| Japan |
Condition
Condition
Stomatitis and Xerostomia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study has 4 objectives as follows;
1) effects on amounts and flora of oral bacteria
2) moisturizing effect on oral mucosa
3) sensory evaluation
4) irritative effects on oral muscosa
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1) reduction of oral bacterial DNA amount by quantitative analysis using polymerase chain reaction method
2) preserved pattern of oral bacterial DNA by evaluation using terminal restriction fragment length polymorphism method
3) preserved moisture on oral mucosa by measurement using oral mucosa moisture checker
4) no inflammation on oral mucosa by clinical observation
Key secondary outcomes
Questionnaire
1) acceptable sensation on oral mucosa
2) no irritative sensation on oral mucosa
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
cetylpyridinium chloride oral ointment containing phosphorylated pullulan
and
ointment base
Interventions/Control_2
cetylpyridinium chloride oral ointment containing phosphorylated pullulan
and
cetylpyridinium chloride oral ointment
Interventions/Control_3
cetylpyridinium chloride oral ointment
and
ointment base
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
dentists with oral and systemic health
Key exclusion criteria
inflammation in oral cavity
pre-existing diseases
any medication
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6675
stakashi@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pha
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6675
Homepage URL
stakashi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 08 | Month | 20 | 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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013484
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
