Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

• Sponsor: Tokyo Medical and Dental University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00748943
• Collaborator: (none)
• Enrollment: 15
• Duration (Months): 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Halitosis	Other: Chlorine Dioxide	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Oral malodor [7 days]

Secondary Outcome Measures

1. Periodontal bacteria [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 38 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Clinical diagnosis of oral malodor

Exclusion Criteria:

• Oral malodor caused by foods

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tokyo Medical and Dental University

Investigators

• Principal Investigator: Kayoko Shinada, DDS,phD, Dept. of Oral health promotion, Tokyo medical and dental university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00748943
• Other Study ID Numbers: 2_Shinada; 2_Shinada
• First Posted: Sep 9, 2008
• Last Update Posted: Sep 12, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: chlorine; dioxide; mouthwash; halitosis; bacteria; saliva
• Additional relevant MeSH terms: Halitosis; Chlorine dioxide

Study Results

No Results Posted as of Sep 12, 2008