UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The therapeutic effect of automatically continuous diluted sodium hypochlorite water delivering system for controlling dental unit contamination
Title of the study (Brief title)	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	Yuichi Izumi
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45, Yushima Bunnkyo-ku Tokyo
TEL	03-5803-5488
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	otsu.peri@tmd.ac.jp
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45, Yushima Bunnkyo-ku Tokyo
TEL	03-5803-5488
Homepage URL
Email	otsu.peri@tmd.ac.jp

Sponsor
Institute	Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030133