A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2008

Last Updated Date

April 4, 2008

Start Date ^ICMJE

February 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00655772 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with the concentrations of 3 kinds gases of human oral malodor analyzing with gas chromatography. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

Official Title ^ICMJE

A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

Brief Summary

A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

Detailed Description

A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In the first test phase, the subjects in the experimental group were instructed to rinse with the mouthwash containing ClO2 and those in the control group with the placebo mouthwash without ClO2. In the second test phase after one week washout period, same procedure was conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with　GC.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study

Condition ^ICMJE

Halitosis

Intervention ^ICMJE

Other: Chlorine Dioxide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of oral malodor
Rinsing the mouthwash

Exclusion Criteria:

oral malodor caused by foods

Gender

Male

Ages

19 Years to 38 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00655772

Responsible Party

Kayoko Shinada/DDS, PhD, Dept. of Oral health promotion, Tokyo medical and dental university

Study ID Numbers ^ICMJE

1_Shinada

Study Sponsor ^ICMJE

Tokyo Medical and Dental University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kayoko Shinada, DDS, PhD

Dept. of Oral health promotion, Tokyo medical and dental university

Information Provided By

Tokyo Medical and Dental University

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP