UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of a dentifrice containing three kinds of bactericidal ingredients in periodontal patients : a clinical study
Title of the study (Brief title)	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	Takashi Kinumatsu
Organization	Tokyo Dental College
Division name	Department of Periodontology
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	Takashi Kinumatsu
Organization	Tokyo Dental College
Division name	Department of Periodontology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-018-3216-x
Results
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/icdr_e/ctr_view.cgi?recptno=R000026716