UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024398 |
|---|---|
| Receipt number | R000025074 |
| Scientific Title | Clinical trial of tooth paste containing Isopropyl methyl phenol (IPMP) for periodontitis in supportive periodontal therapy (SPT) |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2017/10/17 13:48:08 |
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Basic information
Public title
Clinical trial of tooth paste containing Isopropyl methyl phenol (IPMP) for periodontitis in supportive periodontal therapy (SPT)
Acronym
Clinical trial of tooth paste containing IPMP for periodontitis in SPT
Scientific Title
Clinical trial of tooth paste containing Isopropyl methyl phenol (IPMP) for periodontitis in supportive periodontal therapy (SPT)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shogo Tahashiba |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Biopathological Science
Division name
Department of Pathophysiology - Periodontal Science
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6677
shotakashi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shimoe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Biopathologic
Division name
Department of Pathophysiology - Periodontal Science
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL
086-235-6677
Homepage URL
gmd19073@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025074
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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