UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032902 |
|---|---|
| Receipt number | R000037516 |
| Scientific Title | Study on improvement effect of new oral care device on gingivitis |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/12/07 10:30:59 |
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Basic information
Public title
Study on improvement effect of new oral care device on gingivitis
Acronym
Verification of effect of new oral care device
Scientific Title
Study on improvement effect of new oral care device on gingivitis
Scientific Title:Acronym
Verification of effect of new oral care device
Region
| Japan |
Condition
Condition
Gingivitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate effect of new electric tooth brush device with monitor for visualization and digitization of dental plaque on removing dental plaque in self oral care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gingival index at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention
Key secondary outcomes
patient hygiene performance at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention
Questionnaire investigation on oral health before and after experiment
ADCheck at baseline,at 1 week after cessation of toothbrushing, and at additional 1 week after intervention
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
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration of intervention: 1 week
Frequency of intervention: 1 time
Interventions/Control_2
Duration of intervention: 1 week
Frequency of intervention: 1 time
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy persons without gingivaitis
Key exclusion criteria
Person suffered from severe gingivitis for the duration of examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Akifusa |
Organization
Kyushu Dental University
Division name
School of Oral Health Sciences
Zip code
Address
2-6-1, Manazuru, Kokurakita, Kitakyush-shi
TEL
093-285-3107
r11akifusa@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumio Akifusa |
Organization
Kyushu Dental University
Division name
School of Oral Health Sciences
Zip code
Address
2-6-1, Manazuru, Kokurakita, Kitakyush-shi
TEL
093-285-3107
Homepage URL
r11akifusa@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
Other
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
九州歯科大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037516
