UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025422
Receipt No. R000019464
Scientific Title Clinical effect test of the toothpaste containing isopropyl methylphenol (IPMP) to periodontitis on suportive periodontal theraphy (SPT) phase
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Shogo Takashiba
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Pathophysiology - Periodontal Science
Zip code
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
Middle name
Last name Shogo Takashiba
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Pathophysiology - Periodontal Science
Zip code
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
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 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
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
2016 Year 12 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.