UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005844 |
|---|---|
| Receipt number | R000006781 |
| Scientific Title | Clinical multi-center study of OTC periodontal ointment-containing applicator with brush (MC2) for reducing risk of relapse of chronic periodontitis during supportive periodontal therapy |
| Date of disclosure of the study information | 2011/06/24 |
| Last modified on | 2016/12/27 12:05:51 |
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Basic information
Public title
Clinical multi-center study of OTC periodontal ointment-containing applicator with brush (MC2) for reducing risk of relapse of chronic periodontitis during supportive periodontal therapy
Acronym
Clinical multi-center study of OTC periodontal ointment-containing applicator with brush (MC2)
Scientific Title
Clinical multi-center study of OTC periodontal ointment-containing applicator with brush (MC2) for reducing risk of relapse of chronic periodontitis during supportive periodontal therapy
Scientific Title:Acronym
Clinical multi-center study of OTC periodontal ointment-containing applicator with brush (MC2)
Region
| Japan |
Condition
Condition
chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
OTC periodontal ointment-containing applicator with brush (MC2) is a medication enclosing of three active compounds of bactericidal agent, anti-inflammatory agent and tissue regeneration and wound healing agent. This study aims to examine clinical and microbacteriological effectiveness of MC2 for a maintaining and improvement of chronic periodontitis during SPT in a multi-center study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Probing pocket depth(PPD)
Bleeding score(BOP score)
Gingival index(GI)
Key secondary outcomes
Number of bacteria in subgingival plaque
Clinical attachment level(CAL)
Plaque control record(PCR)
Probing attachment level in horizontal and vertical direction(PAL-H, PAL-V)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
test
After it brushes with a prescribed fluoridated dentifrice and a toothbrush, the proper quantity (rice grain outline 0.03g teeth) of the test preparations spread two times of the day (morning and evening) on the marginal gingiva of corresponding molar for 12 weeks.
Interventions/Control_2
placebo
After it brushes with a prescribed fluoridated dentifrice and a toothbrush, the proper quantity (rice grain outline 0.03g teeth) of the placebo preparations spread two times of the day (morning and evening) on the marginal gingiva of corresponding molar for 12 weeks.
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) Person who has ended initial preparation (Surgical treatment is included) of chronic periodontitis, stabilizes the condition, and passes one year or more from SPT beginning in the university hospitals of the clinical trial.
(2) 20-year-old or more person
(3) Person who remains 15 present numbers or more of teeth
(4) Person whom explanation is received by using explanation book, and patient himself agrees to by document
Key exclusion criteria
(1) Person while being getting pregnant or suckling
(2) Person who has allergy symptom for either of three active compounds (cetylpyridinium chloride, dipotassium glycyrrhizate and allantoin)
(3) Person who has systemic disease (diabetic and autoimmune disease) that influences periodontal tissue
(4) Person who takes anticoagulant or has tendency to hemorrhages
(5) Person of while undergoing cancer therapy
(6) Person who received organ transplant in the past
(7) Person who took medicines such as antibiotics and antiphlogistic within three months in the past
(8) Person who did local drug delivery system of antibiotic in mouth within three months in the past
(9) Person who judged that charge dentist is not suitable
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6675
stakashi@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Takashiba |
Organization
Okayama University
Division name
Department of Pathophysiology - Periodontal Science, Graduate School of Medicine, Dentistry and Pha
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 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
University of Tokushima Graduate School
Tokyo Medical and Dental University
Osaka University Graduate School of Dentistry
Tsurumi University School of Dental Medicine
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
岡山大学病院（岡山県）、徳島大学病院（徳島県）、東京医科歯科大学歯学部附属病院（東京都）、大阪大学歯学部附属病院（大阪府）、鶴見大学歯学部附属病院（神奈川県）
Okayama University Hospital(Okayama), Tokushima University Hospital(Tokushima), Tokyo Medical and Dental University Hospital Faculty of Dentistry(Tokyo), Okasa University Dental Hospital(Osaka), Tsurumi University Dental Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 24 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006781
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