Efficacy of Breathspray on Oral malodor and Gingiivtis

Objective: The purpose of this study was to evaluate the effectiveness of GoSMILE's breath spray product containing smileceuticals (ingredients with a unique composition of natural extracts, antioxidants, vitamins and minerals) vs. a placebo breath spray in reducing and preventing oral malodor (OM), gingivitis and supra-gingival plaque in a six-week double-blind clinical trial. Methods: Subjects (18-75 yrs.) were screened according to the selective criteria. Thirty subjects were enrolled and randomly assigned to one of two groups. Group 1 subjects were given the active breath spray product and Group 2 subjects were given the placebo. Subjects in both groups were given usage instructions to use the assigned spray three times a day (two squirts of the spray each time) for six weeks. The subjects were evaluated at baseline and at six weeks using the following clinical parameters: Independent Organoleptic Judges (OJs) scores based on the five-point OM scale, plaque and gingival indices and oralchroma (portable gas chromatography) measurements. Results: Twenty-seven subjects completed the six-week clinical trial: 15 from Group 1 (active) and 12 from Group 2 (placebo). Independent t-tests were used to compare means, and non-parametric comparisons were made using Wilcoxon rank sum tests. Group 1 showed a statistically significant improvement after six weeks for plaque and gingival indices (gingival index p>0.006 and plaque index p>0.006). The OJ score results showed a significant reduction in OM of 65%. Volatile sulfur compounds, which contribute to OM, were measured via gas chromatography. A decrease in overall values for hydrogen sulfide, methyl mercaptan and methyl disulfide were observed, consistent with the OJ score results. Conclusion: This data confirms that the breath spray containing active ingredients significantly improved oral health by reducing oral malodor, plaque and gingivitis.