UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022691 |
|---|---|
| Receipt number | R000026155 |
| Scientific Title | A study on the effect to physiological responses of oral tissue by physiological therapy. |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2016/07/01 09:13:52 |
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Basic information
Public title
A study on the effect to physiological responses of oral tissue by physiological therapy.
Acronym
Efficacy test of physiological therapy for physiological responses of oral tissue.
Scientific Title
A study on the effect to physiological responses of oral tissue by physiological therapy.
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Yano Yoshitaka |
Organization
Kao Corporation
Division name
R&D-Development Research-Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL
03-5630-9751
yanou.yoshitaka@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Fujii |
Organization
Kao Corporation
Division name
R&D-Development Research-Personal Health Care Products Research
Zip code
Address
2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN
TEL
03-5630-9750
Homepage URL
fujii.maiko@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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)
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
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 |
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
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026155
