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

Halitosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655772
• Other study ID #: 1_Shinada
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2008
• Last updated: April 4, 2008
• Start date: February 2007
• Est. completion date: April 2007

Study information

• Verified date: March 2008
• Source: Tokyo Medical and Dental University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 38 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of oral malodor

• Rinsing the mouthwash

Exclusion Criteria:

• oral malodor caused by foods

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Halitosis

Intervention

Other:
• Chlorine Dioxide
Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.

Locations

Country	Name	City	State
Japan	Dept. Oral health promotion, Tokyo medical and dental university	Yushima Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements.		4 hours	Yes
Secondary	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.		4 hours	Yes