UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of a novel device for the treatment of periodontitis by applying a radical disinfection technique
Title of the study (Brief title)	A new disinfection device for the treatment of periodontitis
Region	Japan

Condition
Condition	Periodontal disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study is to verify the safety and the efficacy of a novel device for the treatmet of periodontal disease by applying photolysis of hydrogen peroxide disinfection technique.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	probing pocket depth, bleeding on probing, x-ray examination
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Disinfection treatment using the novel device after conventional ultrasoud scaling and root plaining
Interventions/Control_2	Periodontal pocket irrigation using water after conventional ultrasoud scaling and root plaining
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	35 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who suffer from generalized chronic periodontitis with 2 or more teeth which have >=5mm periodontal pocket and show positive of bleeding on plobing. Patients who have 20 or more remaining teeth Patients who is systematically healthy
Key exclusion criteria	Smoker Pregnant female Patients who have had antibiotics within the last 6 months
Target sample size	10

Research contact person
Name of lead principal investigator	Taro Kanno
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Fixed Prosthodontics
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-8363
Email	tarou@dent.tohoku.ac.jp

Public contact
Name of contact person	Taro Kanno
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Fixed Prosthodontics
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-8363
Homepage URL
Email	tarou@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Mministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
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	2012 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 12 Day
Anticipated trial start date	2012 Year 01 Month 23 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 16 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008622