UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007312
Receipt number R000008622
Scientific Title Clinical evaluation of a novel device for the treatment of periodontitis by applying a radical disinfection technique
Date of disclosure of the study information 2012/02/16
Last modified on 2016/11/21 13:59:05

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Basic information

Public title

Clinical evaluation of a novel device for the treatment of periodontitis by applying a radical disinfection technique

Acronym

A new disinfection device for the treatment of periodontitis

Scientific Title

Clinical evaluation of a novel device for the treatment of periodontitis by applying a radical disinfection technique

Scientific Title:Acronym

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

1st name
Middle name
Last name Taro Kanno

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Fixed Prosthodontics

Zip code


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

1st name
Middle name
Last name Taro Kanno

Organization

Tohoku University Graduate School of Dentistry

Division name

Division of Fixed Prosthodontics

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

022-717-8363

Homepage URL


Email

tarou@dent.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Dentistry

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2012 Year 01 Month 12 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008622


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name