UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038544
Receipt number R000043924
Scientific Title Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index
Date of disclosure of the study information 2019/11/11
Last modified on 2021/10/25 15:53:09

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Basic information

Public title

Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index

Acronym

Examination of tongue coating removal effect using gargle

Scientific Title

Preliminary examination of tongue coating removal effect using oral mucosa oxidol or gargle using the number of bacteria on the tongue as an index

Scientific Title:Acronym

Examination of tongue coating removal effect using gargle

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the clinical effect of various mouthwashes on the tongue

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bacterial counts on the tongue after tongue cleaning

Key secondary outcomes

Bacterial count in saliva after tongue cleaning


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group using Oxol for oral mucosa when cleaning on the tongue(Cleaning only once)

Interventions/Control_2

Group using poppydon iodine for gargle adjusted to the conventional concentration when cleaning on the tongue(Cleaning only once)

Interventions/Control_3

Group using benzalkonium chloride for gargle adjusted to conventional concentration when cleaning on tongue(Cleaning only once)

Interventions/Control_4

Group that uses water to clean the tongue(Cleaning only once)

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

The indicated gargle can be made

Key exclusion criteria

When the consent of the person cannot be obtained.
Patients with a history of hypersensitivity to iodine.
Patients with a history of hypersensitivity to benzalkonium chloride.
Patients with a history of discomfort due to the use of oxidol for oral mucosa.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Madoka
Middle name
Last name Funahara

Organization

School of Oral Health Sciences
Kyushu Dental University

Division name

Unit of Education on Health Promotion

Zip code

803-8580

Address

2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan

TEL

093-285-3109

Email

r17funahara@fa.kyu-dent.ac.jp


Public contact

Name of contact person

1st name Madoka
Middle name
Last name Funahara

Organization

School of Oral Health Sciences Kyushu Dental University

Division name

Unit of Education on Health Promotion

Zip code

803-8580

Address

2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan

TEL

093-285-3109

Homepage URL


Email

r17funahara@fa.kyu-dent.ac.jp


Sponsor or person

Institute

Unit of Education on Health Promotion, School of Oral Health Sciences Kyushu Dental University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Committee, Kyushu Dental University

Address

2-6-1, Manazuru, Kokurakita-ku, Kitakyushu, Japan

Tel

093-285-3011

Email

gakusei@kyu-dent.ac.jp


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

2019 Year 11 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

32

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

2019 Year 05 Month 01 Day

Date of IRB

2019 Year 06 Month 03 Day

Anticipated trial start date

2019 Year 11 Month 11 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2021 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043924


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name