UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036215 |
|---|---|
| Receipt number | 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 23:20:44 |
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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
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
yoshiyam@md.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038664
