UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038564 |
|---|---|
| Receipt number | R000043927 |
| Scientific Title | Usage of Mondamin procare alpha during dental implant treatment |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2019/11/12 19:25:05 |
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Basic information
Public title
Usage of Mondamin procare alpha during dental implant treatment
Acronym
Usage of Mondamin procare alpha during dental implant treatment
Scientific Title
Usage of Mondamin procare alpha during dental implant treatment
Scientific Title:Acronym
Usage of Mondamin procare alpha during dental implant treatment
Region
| Japan |
Condition
Condition
Dental implant treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is very important to keep the environment of oral cavity clean before and after surgery. Although prescription of post-operative gargle is not always necessary, the condition of oral mucosa can be kept healthy by disinfecting the wound with gargle.
Basic objectives2
Others
Basic objectives -Others
Mondamin Procare alpha contains Cetylpyridinium chloride (CPC), tranexamic acid (TXA), and glycyrrhizic acid (GK2).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The purpose of this study is to examine the effect that can be expected by using Mondamin Procare alpha containing CPC, TXA and GK2 as a mouthwash after surgery related to dental implant treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Evaluate the intraoral bacteria after gargle with commercially available Mondamin.
Interventions/Control_2
Evaluate the intraoral bacteria after gargle with placebo Mondamin.
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
Dental implant-adaptable patients without general diseases.
Key exclusion criteria
Not adaptable patients for dental implant treatment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Kuroda |
Organization
Tokyo Medical and Dental University
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku
TEL
03-5803-5773
hidemi.irm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Nakata |
Organization
Tokyo Medical and Dental University
Division name
Oral Implantology and Regenerative Dental Medicine
Zip code
113-8549
Address
1-5-45 Yushima Bunkyo-ku
TEL
03-5803-5773
Homepage URL
hidemi.irm@tmd.ac.jp
Sponsor or person
Institute
Oral Implantology and Regenerative Dental Medicine
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Oral Implantology and Regenerative Dental Medicine
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku
Tel
03-5803-5773
hidemi.irm@tmd.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 | 11 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043927
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
