UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026234 |
|---|---|
| Receipt number | R000030133 |
| Scientific Title | The therapeutic 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 | 2019/02/22 09:48:38 |
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Basic information
Public title
The therapeutic effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Acronym
The therapeutic effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Scientific Title
The therapeutic effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Scientific Title:Acronym
The therapeutic effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Region
| Japan |
Condition
Condition
periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine for the effect of periodontal treatment using 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
After the clinical parameter examined, patients received SPR using ultra sonic scaler.
We evaluated periodontal parameter and quantification of periodontal bacteria in saliva at 1week, 1month and 3month after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients received full-mouth SRP using ultra sonic scaler.
Interventions/Control_2
Patients received full-mouth SRP using ultra sonic scaler at automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit.
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
Each study subject had 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. All subjects were in good general health, and none had received periodontal treatment and/or antibiotic therapy within the preceding 6 months.
Key exclusion criteria
Subjects who were pregnant or lactating and infectious disease were excluded.
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 Bunnkyo-ku Tokyo
TEL
03-5803-5488
y-izumi.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | otsu.peri@tmd.ac.jp |
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 Bunnkyo-ku Tokyo
TEL
03-5803-5488
Homepage URL
otsu.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
Department of Periodontology, Graduate School of Medical and Dental Sciences, 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
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030133
