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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023175
Receipt No. 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

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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
Email 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
Email kinumatu@tdc.ac.jp

Sponsor
Institute Department of Periodontology, Tokyo Dental College
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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