UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025184 |
|---|---|
| Receipt number | R000028970 |
| Scientific Title | A crossover study on efficacy of toothpastes for periodontal patients under maintenance care |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2020/01/28 14:34:53 |
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Basic information
Public title
A crossover study on efficacy of toothpastes for periodontal patients under maintenance care
Acronym
Efficacy of toothpastes for periodontal patients under maintenance care
Scientific Title
A crossover study on efficacy of toothpastes for periodontal patients under maintenance care
Scientific Title:Acronym
Efficacy of toothpastes for periodontal patients under maintenance care
Region
| Japan |
Condition
Condition
Periodontal patients under maintenance care
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of a test toothpaste for reducing dental plaque and improving gingival health of three months duration in comparison with a placebo toothpaste.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
M-QHI,PD,BoP,GI
Key secondary outcomes
DMF
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply testtoothpaste in dairy tooth brushing at least twice a day for three months.
Interventions/Control_2
Apply placebo toothpaste in dairy tooth brushing at least twice a day for three months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients under maintenance care periodically in institutions of this study.
Key exclusion criteria
Subjects deemed inappropriate to participate in this study from the safety aspect by the principle investigator (dentist).
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sugihara |
Organization
Tokyo dental college
Division name
Dept. of Epidemiology and Public Health
Zip code
101-0061
Address
2-9-18,Misaki-cho, Chiyoda-ku, Tokyo
TEL
03-6380-9272
sugihara@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sugihara |
Organization
Tokyo dental college
Division name
Dept. of Epidemiology and Public Health
Zip code
101-0061
Address
2-9-18,Kanda-Misaki-cho, Chiyoda-ku, Tokyo
TEL
03-6380-9272
Homepage URL
sugihara@tdc.ac.jp
Sponsor or person
Institute
Tokyo dental college
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
Tokyo dental college
Address
2-9-18,Kanda-Misaki-cho, Chiyoda-ku, Tokyo
Tel
03-6380-9054
dshomu@tdc.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
藤関歯科医院（東京都）
杉山歯科医院(千葉県）
木暮歯科クリニック（東京都）
平井義人歯科医院(東京都）
石川歯科クリニック（栃木県）
おかもと歯科医院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
33
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
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028970
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/06/11 | 20180611111013638.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
