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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034097
Receipt No. R000038853
Scientific Title Study on preventive effect of mouth wash against mucosa around the dental implant.
Date of disclosure of the study information 2018/09/12
Last modified on 2018/09/12

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Basic information
Public title Study on preventive effect of mouth wash against mucosa around the dental implant.
Acronym Study on preventive effect of mouth wash against mucosa around the dental implant.
Scientific Title Study on preventive effect of mouth wash against mucosa around the dental implant.
Scientific Title:Acronym Study on preventive effect of mouth wash against mucosa around the dental implant.
Region
Japan

Condition
Condition Peri-implant mucositis, Peri-implantitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The clinical findings of the implant around the longitudinal used mouthwashes investigated in implant patients, to elucidate the efficacy of mouthwashes combination of self-care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gingival index
Key secondary outcomes pocket probing depth, bleeding on probing, plaqe index

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 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tap water
Intervention period: 1 month
ervention amount: 1 times 100mL
times: twice daily

Interventions/Control_2 Cetylpyridinium chloride hydrate
Intervention period: 1 month
Intervention amount: 1 times 100mL
times: twice daily
Interventions/Control_3 Chlorhexidine gluconate
Intervention period: 1 month
Intervention amount: 1 times 25-50mL
times: twice daily
Interventions/Control_4 Povidone-iodine
Intervention period: 1 month
Intervention amount: 1 times 60mL
times: twice daily
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 Implant treatment has been completed.
Age is a full 20 years of age or older at the time of obtaining informed consent.
Patients written consent was obtained.

Key exclusion criteria Not subjected to implant treatment.
Hypersensitivity to mouthwash.
It determined that the other researcher is not suitable as research subjects.

Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KIYOSHI KOYANO
Organization Kyushu University Hospital
Division name Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6441
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name CHIKA ARIMIZU
Organization Kyushu University Hospital
Division name Department of Medical Technology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-6441
Homepage URL
Email chika-dh@med.kyushu-u.ac.jp

Sponsor
Institute Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization nothing
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
Address
Tel
Email

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
2018 Year 09 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2022 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038853

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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