Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

Halitosis Clinical Trial

Official title:

The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748943
• Other study ID #: 2_Shinada
• Secondary ID: 2_Shinada
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2008
• Last updated: September 11, 2008
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: September 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

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Description:

Background: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been evaluated and reported, however, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Methods: A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8) were instructed to rinse with the experimental mouthwash containing ClO2 twice per day for 7 days, and those in group 2 (N = 7) to rinse with the control (placebo) mouthwash without ClO2. In the second test, phase after a one week washout period, each group had used the opposite mouthwash for 7 days. At baseline and after 7 days, oral malodor was evaluated with OM, and concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were evaluated with GC. Clinical outcome variables included plaque and gingival indices, and the Winkel Tongue Coating Index(WTCI). The samples of saliva were microbiologically investigated.

Outcome variables were compared by t-test and Mann-Whitney test.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Clinical diagnosis of oral malodor

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®) contained 0.16% sodium chlorite (NaClO2)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical and Dental University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral malodor		7 days	Yes
Secondary	Periodontal bacteria		7 days	Yes