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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036215
Receipt No. R000038664
Scientific Title Clinical effects of mouthwash 'MONDAHMINE PREMIUM CARE sensitive' on dental diseases
Date of disclosure of the study information 2019/05/07
Last modified on 2019/09/29

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Basic information
Public title Clinical effects of mouthwash 'MONDAHMINE PREMIUM CARE sensitive' on dental diseases
Acronym Clinical effects of 'MONDAHMINE PREMIUM CARE sensitive'
Scientific Title Clinical effects of mouthwash 'MONDAHMINE PREMIUM CARE sensitive' on dental diseases
Scientific Title:Acronym Clinical effects of 'MONDAHMINE PREMIUM CARE sensitive'
Region
Japan

Condition
Condition Periodontal disease
Root caries
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effects of 'MONDAHMINE PREMIUM CARE sensitive' on prophylaxis and management of dental diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Probing pocket depth
Key secondary outcomes Bleeding on probing
Plaque Index
State of root caries
Symptoms of dentin hyperesthesia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Mouth rinse using 'MONDAHMINE PREMIUM CARE sensitive', 3 times a day after each meals, for 4 weeks.
During the test period, use of dentifrice on brushing is prohibited.



Interventions/Control_2 Mouth rinse using placebo mouthwash, 3 times a day after each meals, for 4 weeks.
During the test period, use of dentifrice on brushing is prohibited.
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. Those who have completed active dental treatment
2. Those who agreed to participate in the study with written informed consent
Key exclusion criteria 1. Those who received dental treatment (including tooth surface cleaning and oral hygiene guidance by experts) during the study period
2. Those who have taken medications (anti-allergic agents, antibiotics, anti-inflammatory analgesics, etc.) that may influence the judgment of the test during the study period
3. Those who judged inappropriate by the examination dentist
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name YOSHIYAMA
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of Operative Dentistry
Zip code 700-8525
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6672
Email yoshiyam@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name YOSHIYAMA
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name Department of Operative Dentistry
Zip code Department of Operative Dentistry
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6672
Homepage URL
Email yoshiyam@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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, Japan
Tel 086-235-6938
Email 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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 07 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 15 Day
Date of IRB
2019 Year 04 Month 23 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2021 Year 05 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038664

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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