Clinical trial NCT00748943: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Halitosis
Keywords: chlorine
dioxide
mouthwash
halitosis
bacteria
saliva
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of oral malodor

Exclusion Criteria:

* Oral malodor caused by foods

Primary outcomes:
measure: Oral malodor
timeFrame: 7 days
Secondary outcomes:
measure: Periodontal bacteria
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Oral health promotion, Tokyo medical and dental university
name: Kayoko Shinada, DDS,phD
role: PRINCIPAL_INVESTIGATOR
References:
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.