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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011530
Receipt No. 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

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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
Email 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
Email stakashi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013484

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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