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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002145
Receipt No. 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

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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
Institute Osaka University Dental Hospital Department of Preventive Dentistry
Institute
Department

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
URL(English) https://upload.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


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