UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the Effects of Cetylpyridinium Chloride Oral Ointment Containing Phosphorylated Pullulan on Oral Microflora and Oral Mucosa
Title of the study (Brief title)	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	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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	Shogo Takashiba
Organization	Okayama University
Division name	Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pha
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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