UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect to physiological responses of oral tissue by physiological therapy.
Title of the study (Brief title)	Efficacy test of physiological therapy for physiological responses of oral tissue.
Region	Japan

Condition
Condition	Gingivitis, Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of physiological therapy for oral tissue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dynamics of gingival blood flow before and after physiological therapy.
Key secondary outcomes	Blood pressure Probing pocket depth (PPD) Gingival index (GI) Bleeding on probing (BOP) Dental plaque Intra oral photos

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Apply the physiological therapy A for oral tissue 30 seconds at a single time.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male
Key inclusion criteria	Periodontally healthy males
Key exclusion criteria	1. Subjects who received treatment of dental caries or periodontal disease in dental clinic 2. Subjects with serious wound in the oral cavity 3. Subjects with acute inflammation of the gingiva 4. Subjects with tooth mobility 5. Severe periodontitis patients 6. Subjects with denture for maxillary anterior teeth 7. Smokers 8. Subjects who are taking psychotropic drug and/or hypotensive drug
Target sample size	45

Research contact person
Name of lead principal investigator	Yano Yoshitaka
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9751
Email	yanou.yoshitaka@kao.co.jp

Public contact
Name of contact person	Maiko Fujii
Organization	Kao Corporation
Division name	R&D-Development Research-Personal Health Care Products Research
Address	2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL	03-5630-9750
Homepage URL
Email	fujii.maiko@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 06 Day
Anticipated trial start date	2016 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 06 Month 10 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026155