UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023175 |
|---|---|
| Receipt number | R000026716 |
| Scientific Title | Preventive effect of a dentifrice containing three kinds of bactericidal ingredients in periodontal patients : a clinical study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/01/15 09:06:10 |
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Basic information
Public title
Preventive effect of a dentifrice containing three kinds of bactericidal ingredients in periodontal patients : a clinical study
Acronym
Effectiveness of a dentifrice containing three kinds of bactericidal ingredients
Scientific Title
Preventive effect of a dentifrice containing three kinds of bactericidal ingredients in periodontal patients : a clinical study
Scientific Title:Acronym
Effectiveness of a dentifrice containing three kinds of bactericidal ingredients
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of a dentifrice which contains three kinds of bactericidal ingredients on periodontal disease are assessed in patients undergoing SPT.
Inflammatory markers of gingival crevicular fluid (GCF) and the presense of periodontopathic bacteria (5 species) in saliva are also assessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Probing depth
Key secondary outcomes
Clinical attachment level
Plaque Index
Gingival Index
Gingival swelling
Gingival redness
Inflammatory markers of gingival crevicular fluid (GCF)
Periodontal pathogens
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brushing with a dentifrice (OC1510) offered to participants for 28 days.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who agreed to participate in the study with written informed consent.
2. The SPT patients with mild to moderate periodontitis at least one site with PD >=4 mm and GI1 or GI2.
Key exclusion criteria
1. Those with uncontrolled systemic diseases (ex. diabetes, hyperlipidemia, cardiovascular diseases, osteoporosis, autoimmune diseases)
2. Those with severe dental problems not suitable for this study
3. Those under periodontal therapy
4. Smokers
5. History of antimicrobial treatment or taking dietary supplements within 3 months
6. Those who received SRP within 3 months
7. Those who are already using a similar to present investigational dentifrice
8. Those who are judged as inappropriate by an attending dentist
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kinumatsu |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 1010061 Japan
TEL
03-6380-9172
kinumatu@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kinumatsu |
Organization
Tokyo Dental College
Division name
Department of Periodontology
Zip code
Address
2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 1010061 Japan
TEL
03-6380-9172
Homepage URL
kinumatu@tdc.ac.jp
Sponsor or person
Institute
Department of Periodontology, Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
東京歯科大学千葉病院（千葉県） Tokyo Dental College Chiba hospital
(Chiba)
東京歯科大学水道橋病院（東京都） Tokyo Dental College Suidobashi
Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-018-3216-x
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
| 2016 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 20 | 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 | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026716
| 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 |
