UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025422 |
|---|---|
| Receipt number | 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 | 2021/10/19 13:52:30 |
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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
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
stakashi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019464
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