UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002145
Receipt number R000002623
Scientific Title Randomized controlled trial on an effect of preparation of botanical extract on physiological halitosis.
Date of disclosure of the study information 2009/08/01
Last modified on 2010/02/16 17:24:47

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Basic information

Public title

Randomized controlled trial on an effect of preparation of botanical extract on physiological halitosis.

Acronym

Effect of preparation of botanical extract on physiological halitosis.

Scientific Title

Randomized controlled trial on an effect of preparation of botanical extract on physiological halitosis.

Scientific Title:Acronym

Effect of preparation of botanical extract on physiological halitosis.

Region

Japan


Condition

Condition

Physiological halitosis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study evaluates the long-term effect of preparation of botanical extract on physiological halitosis in a randomized controlled trial.
Subjects are randomized to two groups: experimental group takes preparation of botanical extract and control group takes placebo during four weeks.
Oral malodor is assessed by organoleptic teste and measurement of volatile sulfur compounds. Furthermore, salivary periodontal pathogens related with oral malodor are examined.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

organoleptic score, measurement of volatile sulfur compounds in breath, periodontal pathogens in saliva

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Preparation of botanical extract group: During the 4 weeks, subjects eat two tablets of preparations five times per day (after three main meals, between one of the main meals and before bedtime).

Interventions/Control_2

Placebo group: During the 4 weeks, subjects eat two tablets of control preparations five times per day (after three main meals, between one of the main meals and before bedtime).

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects with physiological halitosis
# Organoreptic score >=2 and total volatile sulfur compounds >=0.15 ppm
# All periodontal probing depth of six teeth selected from the six areas <4mm
# Mean gingival index <2 and mean plaque index <2

Key exclusion criteria

Subjects without physiological halitosis
A history of systemic disease
Antibiotic treatment or periodontal treatment within the previous 3 months

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Muneo Tanaka

Organization

Osaka University Dental Hospital

Division name

Department of Preventive Dentistry

Zip code


Address

1-8, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-2922

Email



Public contact

Name of contact person

1st name
Middle name
Last name Muneo Tanaka

Organization

Osaka University Dental Hospital

Division name

Department of Preventive Dentistry

Zip code


Address

1-8, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-2922

Homepage URL


Email



Sponsor or person

Institute

Osaka University Dental Hospital Department of Preventive Dentistry

Institute

Department

Personal name



Funding Source

Organization

Foodstuffs company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2009 Year 08 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

2009 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 06 Month 30 Day

Last modified on

2010 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002623


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name