UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028808 |
|---|---|
| Receipt number | R000032971 |
| Scientific Title | A Study on the dynamics of gingival blood flow |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/06/15 17:14:26 |
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Basic information
Public title
A Study on the dynamics of gingival blood flow
Acronym
A Study on the dynamics of gingival blood flow
Scientific Title
A Study on the dynamics of gingival blood flow
Scientific Title:Acronym
A Study on the dynamics of gingival blood flow
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of physiological stimuli and physical therapy to the dynamics of gingival blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the gingival blood flow before and after the physiological stimuli/single treatment with the physical therapy, and after the repeated treatment for 2,4 and 8 weeks with the physical therapy
Key secondary outcomes
Probing pocket depth (PPD)
Gingival index (GI)
Bleeding on probing (BOP)
Dental plaque
PMA Index
Color of gingiva
Blood pressure
Heart rate
Electrocardiogram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Apply the physical therapy for gingiva more than once a day for 8 weeks
Interventions/Control_2
Do not apply any physical therapy for gingiva for 8 weeks
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 and Female
Key inclusion criteria
Healthy males and females with healthy gingiva
Key exclusion criteria
-Subjects who are under dentist's/doctor's treatment
-Subjects with serious wound in the oral cavity
-Subjects with acute inflammation of the gingiva
-Subjects with tooth mobility
-Severe periodontitis
-Hypertension
-Pregnancies
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Niki |
Organization
Kao Corporation
Division name
Personal Healthcare Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9848
niki.yoshifumi@kao.co.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Ohsugi |
Organization
Kao Corporation
Division name
Personal Healthcare Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7486
Homepage URL
ohsugi.yuko@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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.co.jp
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
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
60
Results
a
Results date posted
| 2019 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
a
Participant flow
a
Adverse events
a
Outcome measures
a
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032971
