UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034097 |
|---|---|
| Receipt number | 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 | 2022/09/14 10:44:45 |
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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 | YASUNORI |
| Middle name | |
| Last name | AYUKAWA |
Organization
Kyushu University Hospital
Division name
Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
ayukawa@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | CHIKA |
| Middle name | |
| Last name | ARIMIZU |
Organization
Kyushu University Hospital
Division name
Department of Medical Technology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6441
Homepage URL
arimizu.chika.195@m.kyushu-u.ac.jp
Sponsor or person
Institute
Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
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
Section of Implant&Rehabilitative Dentistry Division of Oral Rhabilitation, Faculty of Dental Science, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-6441
arimizu.chika.195@m.kyushu-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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 10 | Day |
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
| 2022 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038853
