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A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor.

ABSTRACT: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO(2)), however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM) or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO(2) on volatile sulfur compounds (VSCs) using gas chromatography (GC). The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO(2) on morning oral malodor using OM and GC.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 ClO(2), and those in group 2 (N = 7) to rinse with the placebo mouthwash without ClO(2). In the second test, phase after a one week washout period, each group used the opposite mouthwash.Oral malodor was evaluated before rinsing, right after rinsing and every 30 minutes up to 4 hours with OM, and concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH(3)SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were evaluated with GC.The baseline oral condition in the subjects in the 2 groups did not differ significantly. The mouthwash containing ClO(2) improved morning bad breath according to OM and reduced concentrations of H(2)S, CH(3)SH and (CH(3)(2)S according to GC up to 4 hours after rinsing. OM scores with ClO(2) were significantly lower than those without ClO(2) at all examination times. Significant reductions in the concentrations of the three kinds of VSCs measured by GC were also evident at all examination times. The concentrations of the three gases with ClO(2) were significantly lower than those without ClO(2) at most examination times.In this explorative study, ClO(2) mouthwash was effective at reducing morning malodor for 4 hours when used by healthy subjects.ClinicalTrials.gov NCT00655772.

SUBMITTER: Shinada K

PROVIDER: S-EPMC2637235 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature

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A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor.

Shinada Kayoko K Ueno Masayuki M Konishi Chisato C Takehara Sachiko S Yokoyama Sayaka S Kawaguchi Yoko Y

Trials 20081209

<h4>Background</h4>Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO(2)), however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurements (OM) or sulphide monitors. No clinical studies have investigated the inhibitory effects of ClO(2) on volatile sulfur compounds (VSCs) using gas chromatography (GC). The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO(2) on mo ...[more]

PMID: 19068114

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Project description:BackgroundPrevious research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been evaluated and reported only in short duration trials, moreover, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. Thus, the aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 used for 7 days on morning oral malodor and on salivary periodontal and malodorous bacteria.Methods/designA randomized, double blind, crossover, placebo-controlled trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. Subjects were instructed to rinse with the experimental mouthwash containing ClO2 or the placebo mouthwash, without ClO2, twice per day for 7 days. After a one week washout period, each group then used the opposite mouthwash for 7 days. At baseline and after 7 days, oral malodor was evaluated with Organoleptic measurement (OM), and analyzed the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were assessed by gas chromatography (GC). Clinical outcome variables included plaque and gingival indices, and tongue coating index. The samples of saliva were microbiologically investigated. Quantitative and qualitative analyses were performed using the polymerase chain reaction-Invader method.Results and discussionThe baseline oral condition in healthy subjects in the 2 groups did not differ significantly. After rinsing with the mouthwash containing ClO2 for 7 days, morning bad breath decreased as measured by the OM and reduced the concentrations of H2S, CH3SH and (CH3)2S measured by GC, were found. Moreover ClO2 mouthwash used over a 7-day period appeared effective in reducing plaque, tongue coating accumulation and the counts of Fusobacterium nucleatum in saliva. Future research is needed to examine long-term effects, as well as effects on periodontal diseases and plaque accumulation in a well-defined sample of halitosis patients and broader population samples.Trial registrationClinicalTrials.gov NCT00748943.

Project description:Paraxanthine (PXN) is a metabolite of caffeine that has recently been reported to enhance cognition at a dose of 200 mg. To determine the acute and short-term (7-day) effects of varying doses of PXN on cognitive function and side effects. In a double blind, placebo-controlled, crossover, and counterbalanced manner, 12 healthy male and female volunteers (22.7 ± 4 years, 165 ± 7 cm, 66.5 ± 11 kg, 24.4 ± 3 kg/m2) ingested 200 mg of a placebo (PLA), 50 mg of PXN (ENFINITY™, Ingenious Ingredients, L.P.) + 150 mg PLA, 100 mg PXN + 100 mg PLA, or 200 mg of PXN. With each treatment experiment, participants completed side effect questionnaires and donated a fasting blood sample. Participants then performed a series of tests assessing cognition, executive function, memory, and reaction time. Participants then ingested one capsule of PLA or PXN treatments. Participants then completed side effects and cognitive function tests after 1, 2, 3, 4, 5, and 6 h of treatment ingestion. Participants continued ingesting one dose of the assigned treatment daily for 6-days and returned to the lab on day 7 to donate a fasting blood sample, assess side effects, and perform cognitive function tests. Participants repeated the experiment while ingesting remaining treatments in a counterbalanced manner after at least a 7-day washout period until all treatments were assessed. The Sternberg Task Test (STT) 4-Letter Length Present Reaction Time tended to differ among groups (p = 0.06). Assessment of mean changes from baseline with 95% CI's revealed several significant differences among treatments in Berg-Wisconsin Card Sorting Correct Responses, Preservative Errors (PEBL), and Preservative Errors (PAR Rules). There was also evidence of significant differences among treatments in the Go/No-Go Task tests in Mean Accuracy as well as several time points of increasing complexity among STT variables. Finally, there was evidence from Psychomotor Vigilance Task Test assessment that response time improved over the series of 20 trials assessed as well as during the 6-h experiment in the PXN treatment. Acute and short-term benefits compared to PLA were seen with each dose studied but more consistent effects appeared to be at 100 mg and 200 mg doses. No significant differences were observed among treatments in clinical chemistry panels or the frequency or severity of reported side effects. Results provide evidence that acute ingestion of 100 mg and 200 mg of PXN may affect some measures of cognition, memory, reasoning, and response time as well as help sustain attention. Additionally, that acute and daily ingestion of PXN for 7 days is not associated with any clinically significant side effects. PXN may serve as an effective nootropic agent at doses as low as 50 mg.

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A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor.

Publications

A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor.

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