Safety and Efficacy Evaluation of Fresh Breath Mouthwash

Objective
This study aimed to assess the safety and efficacy of Fresh Breath Mouthwash in reducing oral malodor.

Process
A 3-week, single-center, randomized, double-blind, placebo-controlled trial was conducted, involving 66 subjects. Participants were randomly assigned to either the active (Group B) or placebo (Group A) groups, with 33 subjects in each. Both groups were instructed to use the product twice a day. Safety and efficacy assessments, focusing on malodor reduction, were conducted at various intervals (Day 0, 12 hours, and 3 weeks) by trained professionals. Oral safety assessments were conducted by a California state licensed dentist. Oral malodor assessments were conducted by a panel of three trained judges using a nine-point hedonic scale, with 0 indicating the most pleasant odor and 9 indicating the most unpleasant odor. The mean organoleptic scores were calculated from the scores provided by all judges during the malodor assessment. Statistical analysis was conducted to assess the significance of observed changes.

Results

Visit	Mean Organoleptic Score
	n	Group A (Placebo)	Group B (Active)	p-Value
Visit 1 (Baseline (0 hr.))	33	7.81	8.10	-
Visit 2 (12 hr.)	33	7.12	6.31	<0.002
Visit 3 (Three Week)	33	6.64	5.32	<0.002

Table1: Mean organoleptic score (These values correspond to the averages of approximately 99 malodor assessment scores, obtained through assessments conducted by three independent malodor expert judges during each visit)

Conclusions
The active group (Group B) exhibited a statistically significant reduction in oral malodor compared to the placebo group (Group A) after both the 12-hour and three-week assessments. The Shapiro-Wiles test confirmed that the distribution of the study sample closely approximated a normal distribution. Notably, no adverse events were reported throughout the study, and no abnormal conditions were observed during oral exams conducted at each visit.

Consequently, no safety concerns emerged during the 3-week product usage. These findings underscore the product's ability to provide effective and long-lasting fresh breath, as per the study's objectives. The outcomes of this study
provide strong support for the claims of "up to 24 Hours Fresh Breath" when used as directed. These findings are not only beneficial for consumers seeking effective oral care solutions but also for healthcare professionals recommending products that deliver both safety and efficacy in maintaining oral wellness.