UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038414 |
|---|---|
| Receipt number | R000043774 |
| Scientific Title | Evaluation of clinical usefulness of an electric tooth brush, Prinia Smile, GC |
| Date of disclosure of the study information | 2019/10/30 |
| Last modified on | 2020/04/28 10:43:47 |
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Basic information
Public title
Evaluation of clinical usefulness of Prinia Smile, GC
Acronym
Evaluation of clinical usefulness of an electric toothbrush
Scientific Title
Evaluation of clinical usefulness of an electric tooth brush, Prinia Smile, GC
Scientific Title:Acronym
Evaluation of clinical usefulness of an electric tooth brush, Prinia Smile, GC
Region
| Japan |
Condition
Condition
Gingivitis and periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will check whether PCR (Plaque Control Record) 20%, which is one of the evaluation criteria when treating periodontal disease, can be achieved by TBI(teeth brushing instructiono) with an electric toothbrush.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Check if PCR(Plaque Control Record) 20% was achieved
Key secondary outcomes
Confirm that no adverse events such as pain occurred
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Get periodontal examination before using electric toothbrush
Interventions/Control_2
Fix the frequency of the electric toothbrush used
Interventions/Control_3
Change the frequency of the electric toothbrush used
Interventions/Control_4
Changing the head of the electric toothbrush used
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Age:Patients who are 20 years of age or older when obtaining consent
(2)Gender:Any
(3)Hospitalization / Outpatient: Outpatient only
(4)Periodontal examination:Patients who have been diagnosed as having moderate or more chronic periodontitis or invasive periodontitis as a result of periodontal examination
(5)Patients who have received sufficient explanation for participation in this study, and who have fully understood and consented to the document by their own will.
(6)Systemic periodontal disease treatment has not been received in the past, or even if it has been received, plaque control is poor and there is a wide range of recurrence sites.
(7)There are more than 20 remaining teeth in all jaws.
8)Antibacterial drugs.You have not taken any antibacterial drugs within the past 3 months on the registration date.
Key exclusion criteria
(1)Patients with diabetes that cannot be controlled
(2)Patients with severe heart disease
(3)Patients with severe liver and renal dysfunction
(4)Patients taking antibody drugs or anti-inflammatory drugs for autoimmune diseases
(5)Other patients who are deemed inappropriate by the research director
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | yamashita |
| Middle name | |
| Last name | yasunori |
Organization
Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Periodontology and Endodontology
Zip code
8528501
Address
1-7-1, sakamoto, nagasaki city, nagasaki prefecture
TEL
095-819-7643
yamachanpon@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | yamashita |
| Middle name | |
| Last name | yasunori |
Organization
Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Periodontology and Endodontology
Zip code
8528501
Address
1-7-1, sakamoto, nagasaki , nagasaki
TEL
095-819-7643
Homepage URL
yamachanpon@nagasaki-u.ac.jp
Sponsor or person
Institute
Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Department of Periodontology and Endodontology
Institute
Department
Personal name
Funding Source
Organization
Medical and Dental Sciences, Graduate School of Biomedical Sciences, Nagasaki University, Department of Periodontology and Endodontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nagasaki university
Address
1-7-1, sakamoto, nagsaki, nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 30 | 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
| 2019 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043774
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
