Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
Primary Purpose
Halitosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chlorine Dioxide
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis focused on measuring chlorine, dioxide, mouthwash, halitosis, bacteria, saliva
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of oral malodor
Exclusion Criteria:
- Oral malodor caused by foods
Sites / Locations
Outcomes
Primary Outcome Measures
Oral malodor
Secondary Outcome Measures
Periodontal bacteria
Full Information
NCT ID
NCT00748943
First Posted
September 8, 2008
Last Updated
September 11, 2008
Sponsor
Tokyo Medical and Dental University
1. Study Identification
Unique Protocol Identification Number
NCT00748943
Brief Title
Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
Official Title
The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo Medical and Dental University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
chlorine, dioxide, mouthwash, halitosis, bacteria, saliva
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Chlorine Dioxide
Other Intervention Name(s)
ClO2 Fresh®
Intervention Description
Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
Primary Outcome Measure Information:
Title
Oral malodor
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Periodontal bacteria
Time Frame
7 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of oral malodor
Exclusion Criteria:
Oral malodor caused by foods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayoko Shinada, DDS,phD
Organizational Affiliation
Dept. of Oral health promotion, Tokyo medical and dental university
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20152022
Citation
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.
Results Reference
derived
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Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
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