UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009436 |
|---|---|
| Receipt number | R000011087 |
| Scientific Title | Phase Clinical Trial of mouth rinsing with MA-T107 in patients with periodontitis |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2015/12/01 10:58:07 |
* 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
Phase Clinical Trial of mouth rinsing with MA-T107 in patients with periodontitis
Acronym
Effect of mouth rinsing with MA-T107 for Periodontitis
Scientific Title
Phase Clinical Trial of mouth rinsing with MA-T107 in patients with periodontitis
Scientific Title:Acronym
Effect of mouth rinsing with MA-T107 for Periodontitis
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a phase1study, we determine the maximum tolerated dose (MTD) and the recommended dose (RD) of stable chlorine dioxide ((Na)ClO2) within MatatacoroTM for treatment of patients with periodontitis. Then, in a phase 2 study, we examined the efficacy and safety of the RD of (Na)ClO2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
VAS-score, Plobing pocket depth, Plobing pocket bleeding, Mean gingival Index and Mean BANA-score
Key secondary outcomes
2 and 4 weeks after first treatment
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
MatatacoroTM of stable chlorine dioxide ((Na)ClO2)
30 sec. at once, twice a day, 1 week, a 30 ml dose, continious 4 weeks
Interventions/Control_2
For MatatacoroTM, an initial dose level is set at 10 ppm, and 3 patients are enrolled for each level of dose escalation.
Interventions/Control_3
The latter phase 2 study was carried out. It was double blind test and compared MatatacoroTM with purified water.
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
patients with periodontitis who was treated first
Key exclusion criteria
heavy general disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kimio Uchiyama |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Department of dentistry and oral surgery
Zip code
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL
028-622-5241
k.uchiyama@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimio Uchiyama |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Department of dentistry and oral surgery
Zip code
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi, Japan
TEL
028-622-5241
Homepage URL
k.uchiyama@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center, Department of dentistry and oral surgery
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Tochigi Medical Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2050185039
Org. issuing International ID_1
Ministry of Health, labor and welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構栃木医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://pubs.sciepub.com/oral/3/1/5
Number of participants that the trial has enrolled
Results
The Effect of Mouth Rinsing with Stabilized Chlorine Dioxide on Periodontitis.
Oral surgery, oral medicine, oral radiology, 2015, Vol.3, No.1, 20-24
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
Main results already published
Date of protocol fixation
| 2011 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2015 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011087
