UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011982 |
|---|---|
| Receipt number | R000014000 |
| Scientific Title | A randomized cross-over study on the inhibitory effect of rice peptide on plaque formation |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2015/10/06 16:11:15 |
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Basic information
Public title
A randomized cross-over study on the inhibitory effect of rice peptide on plaque formation
Acronym
The effect of rice peptide on plaque formation
Scientific Title
A randomized cross-over study on the inhibitory effect of rice peptide on plaque formation
Scientific Title:Acronym
The effect of rice peptide on plaque formation
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine inhibitory effect on plaque formation of mouth rinse containing rice peptide
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To compare the level of plaque formation between the experimental group with rice peptide rince and the control group
Key secondary outcomes
Questionnaire survey about rice peptide mouth rinse
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Subjects are instructed to use 20 ml rice peptide mouth rinse (0.4%) twice a day (in the morning and evening) and stop tooth brushing during 3 days period.
Interventions/Control_2
Control (placebo mouth rinse group)
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
| 24 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those with good general health.
2. Periodontally healthy individuals
3. Those who agreed to participate in the study with written informed consent.
Key exclusion criteria
1. Those with uncontrolled systemic disease
2. Those who received antimicrobial or steroid treatment during the study.
3. Those with untreated dental disease
4. Those with severe malocclusion
5. History of allergic reaction against rice or medication
6. Those who used other oral care material during the study.
7. Those who are judged to be inappropriate to be included in the study by principal investigator or dentist
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Saito |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
Address
1-2-2 Masago, Mihama-ku, Chiba 261-8502 Japan
TEL
043-270-3954
atsaito@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saori Takayama |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
Address
1-2-2 Masago, Mihama-ku, Chiba 261-8502 Japan
TEL
043-270-3954
Homepage URL
saoritakayama@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Agriculture, Forestry and Fisheries Research Council
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
東京歯科大学水道橋病院（東京都）
東京歯科大学千葉病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | 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
| 2013 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014000
