UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043609 |
|---|---|
| Receipt number | R000049622 |
| Scientific Title | An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/03/10 21:44:20 |
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Basic information
Public title
An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Acronym
An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title
An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Scientific Title:Acronym
An Interventional Study on Cleaning Effectiveness and Patients' Attitude Using an Electric Toothbrush
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of using an electric toothbrush during periodontal therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes are set at Plaque Control Record and the result of saliva test(ammonia). These outcomes will obtain at before and after periodontal therapy.
Key secondary outcomes
Secondary outcomes are set at periodontal condition (the percentage of probing depth deeper than 4mm, BOP, PISA) and results of saliva test (bacterial count, acidity, buffering capacity, WBC, protein).These outcomes will obtain at before and after periodontal therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants assigned to use an electric tooth brush use an electric tooth blush (Hypersonic pro) during experimental period.
Interventions/Control_2
Participants assigned to use a hand tooth brush use a hand tooth blush (CURAPROX CS5460) during experimental period.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who come to the Department of Endodontics at Tohoku University Hospital, have at least one periodontal pocket of 4 mm or deeper in the periodontal examination.
Key exclusion criteria
People who are judged to have difficulty in using an electric toothbrush and to have difficulty in participating in the study due to psychosis or psychiatric symptoms.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Graduate School of Dentistry
Division name
Conservative Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL
022-717-8343
mssaito@dent.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Graduate School of Dentistry
Division name
Conservative Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
TEL
022-717-8343
Homepage URL
mssaito@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Fibermedicine
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
Tohoku University Graduate School of Dentistry, Research Ethics Committee
Address
4-1 Seiryo-machi,Aoba-ku,Sendai-city, Miyagi prefecture
Tel
022-717-8343
mssaito@dent.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 13 | Day |
Last modified on
| 2021 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049622
| 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 |
