UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of tooth paste containing Isopropyl methyl phenol (IPMP) for periodontitis in supportive periodontal therapy (SPT)
Title of the study (Brief title)	Clinical trial of tooth paste containing IPMP for periodontitis in SPT
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of Systema SP-T Gel
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bacterial count in subgingival plaque
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	SystemaSP-T Gel use test tooth paste for 8 week
Interventions/Control_2	Placebo (Brilliant more) use test tooth paste for 8 week
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	20 years of age or older of the university faculties, graduate students or research students. A person the procedure of the informed consent has been completed, never forced.
Key exclusion criteria	the exclusion criteria are allergic to this products, and pregnant or lactating.
Target sample size	60

Research contact person
Name of lead principal investigator	Shogo Tahashiba
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Biopathological Science
Division name	Department of Pathophysiology - Periodontal Science
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL	086-235-6677
Email	shotakashi@gmail.com

Public contact
Name of contact person	Masayuki Shimoe
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Biopathologic
Division name	Department of Pathophysiology - Periodontal Science
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL	086-235-6677
Homepage URL
Email	gmd19073@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Lion Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 14 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2017 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 13 Day
Last modified on	2017 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025074