UMIN-CTR Clinical Trial

Basic information
Public title	Clinical effect test of the toothpaste containing isopropyl methylphenol (IPMP) to periodontitis on suportive periodontal theraphy (SPT) phase
Acronym	Clinical effect test of the toothpaste containing IPMP
Scientific Title	Clinical effect test of the toothpaste containing isopropyl methylphenol (IPMP) to periodontitis on suportive periodontal theraphy (SPT) phase
Scientific Title:Acronym	Clinical effect test of the toothpaste containing IPMP
Region	Japan

Condition
Condition	Chronic periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of Systema SP-T gel to periodontitis is estimated clinically and bacteriologically. An efficacy of a medicine ingredient of IPMP is considered.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of bacteria in the subgingival plaque Periodontal pocket depth Bleeding on probing score Gingival index Plaque control record
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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	For 8 weeks twice a day (morning and night), toothpaste including IPMP (1.2-cm length) is used for tooth brushing.
Interventions/Control_2	For 8 weeks twice a day (morning and night), toothpaste excluding IPMP (1.2-cm length) is used for tooth brushing.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) SPT patients who are interval in more than 2 months 2) Those who brush certainly as instructions 3) Those with more than 15 teeth 4) Those with periodontal pockets with 4 - 6 mm depth 5) Those who brush using Bass method or similar methods 6) Those who provided written informed consent
Key exclusion criteria	1) Those with allergies to toothpaste 2) Those who were pregnant or lactating 3) Those with systemic disease that affects periodontal tissue 4) Those who have taken antibiotics and anti-inflammatory agents within 3 months 5) Those who had the acute symptom of periodontitis within 3 months 6) Smokers 7) Those who don't fit the schedule defined
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shogo Middle name Last name Takashiba
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Pathophysiology - Periodontal Science
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL	086-235-6675
Email	stakashi@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Shogo Middle name Last name Takashiba
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Pathophysiology - Periodontal Science
Zip code	7008525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL	086-235-6675
Homepage URL
Email	stakashi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-u.ac.jp

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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Completed
Date of protocol fixation	2016 Year 06 Month 28 Day
Date of IRB	2015 Year 12 Month 22 Day
Anticipated trial start date	2016 Year 06 Month 29 Day
Last follow-up date	2016 Year 12 Month 28 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 27 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019464