A New Portable Monitor for Measuring Odorous Compounds in... | NCT01139073

Studies
A New Portable Monitor for Measuring Odorous Compounds in Oral, Exhaled and Nasal Air

NCT01139073

Sponsor

Okayama University

Status

Completed

Last Update Posted

Jun 8, 2010Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Halitosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Not provided

Completion Date

Apr 2010Actual

First Submitted Date

Jun 7, 2010

First Submission Date that Met QC Criteria

Jun 7, 2010

First Posted Date

Jun 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2010

Last Update Posted Date

Jun 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and nasal air, is now available. As a single unit, this device is capable of assessing several kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker for detecting the malodor level of oral, exhaled, and nasal air.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of oral malodor

Exclusion Criteria:

Smoker
Medical disorders
Undergoing any antibiotic or other antimicrobial therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects were recruited at the Clinic of Preventive Dentistry, Okayama University Hospital.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21504624	Derived	Tamaki N, Kasuyama K, Esaki M, Toshikawa T, Honda S, Ekuni D, Tomofuji T, Morita M. A new portable monitor for measuring odorous compounds in oral, exhaled and nasal air. BMC Oral Health. 2011 Apr 20;11:15. doi: 10.1186/1472-6831-11-15.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms