UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006407
Receipt number R000007601
Scientific Title A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.
Date of disclosure of the study information 2011/12/01
Last modified on 2013/10/11 20:14:55

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Basic information

Public title

A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.

Acronym

A multi-center clinical trial to examine the effects of a mouth rinse on patients with mild periodontal disease.

Scientific Title

A multi-center randomized controlled clinical trial to examine the clinical, biochemical and antimicrobial effects of a mouth rinse on patients with mild periodontal disease.

Scientific Title:Acronym

A multi-center clinical trial to examine the effects of a mouth rinse on patients with mild periodontal disease.

Region

Japan


Condition

Condition

mild periodontal disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this multi-center clinical trial is to examine the clinical, biochemical and antimicrobial effects of a mouth rinse containing cetylpyridinium chloride, triclosan and dipotassium glycyrrhizinate on patients with mild periodontal disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Quigley-Hein plaque index (QHI)
2. Modified gingival index (MGI)
3. Probing pocket depth (PD)
4. Bleeding on probing (BOP)
5. Cytokine levels in gingival crevicular fluid
6. The number of total bacteria and some periodontopathic bacteria in subgingival plaque

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

Test group
First of all, subjects are instructed to brush their teeth as usual twice a day (in the morning and in the evening) with the supplied dentifrice containing sodium fluoride and toothbrush. Then subjects are instructed to rinse with 10 mL of the test mouth rinse for 20 seconds.

Interventions/Control_2

Placebo group
First of all, subjects are instructed to brush their teeth as usual twice a day (in the morning and in the evening) with the supplied dentifrice containing sodium fluoride and toothbrush. Then subjects are instructed to rinse with 10 mL of the placebo mouth rinse for 20 seconds.

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

(1) 20 years old or older persons who obtained written informed consent.
(2) Persons who have good general health with 20 teeth or more.
(3) Persons who have no plan to receive dental treatment during this study period.
(4) Persons who have greater than or equal to 1.5 in QHI (Quigley-Hein Plaque Index) score.
(5) Persons who have greater than or equal to 1.0 and less than 2.3 in MGI (Modified Gingival Index) score.

Key exclusion criteria

(1) Persons who took antibiotics and anti-inflammatory agent (except external use) for the past one month prior to this study.
(2) Persons who use a dental floss or an interdental brush daily.
(3) Persons who have the medical history of hypersensitivity to the ingredients (cetylpyridinium chloride, triclosan, dipotassium glycyrrhizinate and others.) containing the mouth rinse.
(4) Persons who are suspected to be diabetic or pregnant.
(5) Persons who have five or more untreated caries lesions (scored C2 and up).
(6) Severe periodontitis patients with tooth mobility or abscess formation.
(7) Persons who are judged to be unqualified for this study subjects by investigators.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya MURAKAMI

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Periodontology, Division of Oral Biology and Disease control

Zip code


Address

1-8 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-2930

Email

ipshinya@dent.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori KIMURA

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Periodontology, Division of Oral Biology and Disease control

Zip code


Address

1-8 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-2831

Homepage URL


Email

kimura-k@office.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Sunstar Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hiroshima University, Graduate School of Biomedical Sciences, Department of Periodontal Medicine
Aichi-gakuin University, School of Dentistry, Department of Periodontology
Sunstar Inc.

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

2011 Year 12 Month 01 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

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 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

2011 Year 09 Month 26 Day

Last modified on

2013 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name