UMIN-CTR Clinical Trial

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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