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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025184
Receipt No. 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 2018/06/11

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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
Middle name
Last name Naoki Sugihara
Organization Tokyo dental college
Division name Dept. of Epidemiology and Public Health
Zip code
Address 2-9-18,Misaki-cho, Chiyoda-ku, Tokyo
TEL 03-6380-9272
Email sugihara@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Sugihara
Organization Tokyo dental college
Division name Dept. of Epidemiology and Public Health
Zip code
Address 2-9-18,Misaki-cho, Chiyoda-ku, Tokyo
TEL 03-6380-9272
Homepage URL
Email sugihara@tdc.ac.jp

Sponsor
Institute Tokyo dental college
Institute
Department

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
Address
Tel
Email

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 Partially published

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 Main results already published
Date of protocol fixation
2016 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.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


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