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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038564
Receipt No. 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

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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
Email 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
Email hidemi.irm@tmd.ac.jp

Sponsor
Institute Oral Implantology and Regenerative Dental Medicine
Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043927

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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