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

NCT ID: NCT00655772

Last Updated: 2008-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-04-30

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.

Conditions

Halitosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

ClO2 Fresh®

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of oral malodor
• Rinsing the mouthwash

Exclusion Criteria

• oral malodor caused by foods

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tokyo Medical and Dental University

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Kayoko Shinada, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Dept. Oral health promotion, Tokyo medical and dental university

Yushima Bunkyo-ku, Tokyo, Japan

Countries

Japan

References

Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Kawaguchi Y. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor. Trials. 2008 Dec 9;9:71. doi: 10.1186/1745-6215-9-71.

Reference Type: DERIVED

PMID: 19068114 (View on PubMed)

Other Identifiers

1_Shinada

Identifier Type: -

Identifier Source: org_study_id