UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028532 |
|---|---|
| Receipt number | R000032655 |
| Scientific Title | A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush |
| Date of disclosure of the study information | 2017/08/04 |
| Last modified on | 2021/08/20 07:46:48 |
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Basic information
Public title
A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Acronym
Effect of professional instruction for patients first using an electric toothbrush
Scientific Title
A study on effect of professional instruction for efficiency to remove dental plaque on patients first using an electric toothbrush
Scientific Title:Acronym
Effect of professional instruction for patients first using an electric toothbrush
Region
| Japan |
Condition
Condition
Periodontitis, gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of professional instructions for removing dental plaque on the patient using an electric toothbrush for the first time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque Index after two weeks using an electrical toothbrush
Key secondary outcomes
Gingival Index after two weeks using an electrical toothbrush
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Receive professional instruction before using an electric toothbrush
Interventions/Control_2
Use an electric toothbrush without professional instruction
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Volunteer who has never used an electric toothbrush and has target teeth, and no prosthetic for them.
Subjects with probing depth <= 4 mm
Key exclusion criteria
Dentistry worker
Subjects who are treated for periodontal disease within three months
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Morotomi |
Organization
Kyushu Dental University
Division name
Division of Endodontics and Restorative Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL
+81-93-582-1131
r13morotomi@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Morotomi |
Organization
Kyushu Dental University
Division name
Division of Endodontics and Restorative Dentistry
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu 803-8580 Japan
TEL
+81-93-582-1131
Homepage URL
r13morotomi@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokuyama dental Corp.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental Univercity
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu City.
Tel
093-582-1131
r13morotomi@fa.kyu-dent.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
九州歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032655
| 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 |
