UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026237 |
|---|---|
| Receipt number | R000030137 |
| Scientific Title | The treatment effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2020/02/29 13:17:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The treatment effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Acronym
The treatment effect of automatically continuous diluted sodium hypochlorite water
Scientific Title
The treatment effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Scientific Title:Acronym
The treatment effect of automatically continuous diluted sodium hypochlorite water
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine clinical and microbiological effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical examination was performed at baseline and 4 and 12 weeks after treatment. Microbiological examination was carried out just before and after treatment and at 1 and 12 weeks posttreatment.
Key secondary outcomes
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Full-mouth mechanical debridement with tap water.
Interventions/Control_2
Full-mouth mechanical debridement with automatically continuous diluted sodium hypochlorite water.
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
A minimum of 20 teeth present and exhibited at least one pocket site with a probing depth of 4 mm or more in each quadrant.
Good general health
None had received periodon- tal treatment and/or antibiotic therapy within the preceding 6 months
Key exclusion criteria
Pregnant or lactating
Smoker
Infectious disease
Diabetes milites
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Izumi |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
03-5803-5488
y-izumi.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Takeuchi |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo 113-8549, Japan
TEL
03-5803-5488
Homepage URL
takeuchi.peri@tmd.ac.jp
Sponsor or person
Institute
Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
J. Morita Tokyo Mfg. Corp., Saitama, Japan
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
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
| 2017 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030137
