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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009436
Receipt No. 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

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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
Email 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
Email k.uchiyama@tochigi-mc.jp

Sponsor
Institute National Hospital Organization Tochigi Medical Center, Department of dentistry and oral surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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