Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

This study has been completed.
Sponsor:
Information provided by:
Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT00748943
First received: September 8, 2008
Last updated: September 11, 2008
Last verified: September 2008

September 8, 2008
September 11, 2008
March 2007
May 2007   (final data collection date for primary outcome measure)
Oral malodor [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00748943 on ClinicalTrials.gov Archive Site
Periodontal bacteria [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Halitosis
Other: Chlorine Dioxide
Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
Other Name: ClO2 Fresh®
Not Provided
Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of oral malodor

Exclusion Criteria:

  • Oral malodor caused by foods
Male
19 Years to 38 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00748943
2_Shinada, 2_Shinada
No
Kayoko Shinada/DDS, phD, Dept. of Oral health promotion, Tokyo medical and dental university
Tokyo Medical and Dental University
Not Provided
Principal Investigator: Kayoko Shinada, DDS,phD Dept. of Oral health promotion, Tokyo medical and dental university
Tokyo Medical and Dental University
September 2008

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