Safety and Efficacy of Gurunanda® Oil Pulling Rinse in Reducing Oral Malodor.

Objective

The purpose of this study was to assess the safety and effectiveness of Gurunanda® Oil Pulling Rinse in mitigating oral malodor.

 

Process

A single center, randomized, double-blind, placebo control clinical study in 60 subjects was conducted to evaluate the safety and efficacy of Gurunanda® Oil Pulling Rinse over a 3-week duration. Suitable inclusion and exclusion criteria were established to eliminate any potential biases. A total of approximately 30 subjects were randomly assigned to both the active group (Group B) and the placebo group (Group A). Subjects were instructed to use the study article once a day for 2 minutes. Safety and efficacy (malodor) assessments were performed at various intervals (0 hr., 12 hr., and 3 weeks) by trained and qualified 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. To compare the mean score change from visit 1 across visits 2 and 3, a repeated measure (mixed) analysis of variance (ANOVA) model was utilized. The model allowed for the calculation of p-values to assess the significance of the observed changes.

 

Results:

Visit

Mean Organoleptic Score

n

Group A (Placebo)

n

Group B (Active)

Visit 1 (Baseline (0 hr.))

29

8.00

31

8.20

Visit 2 (12 hr.)

29

7.57

31

7.31

Visit 3 (Three Week)

29

7.16

31

5.58

Table1: Mean organoleptic score (These values correspond to the averages of approximately 90 malodor assessment scores, obtained through assessments conducted by three independent malodor expert judges during each visit) 

 

 

Group A

Group B

Mean Difference

|A-B|

p-Value

Visit 2 (12 hr.)

0.43

0.89

0.46

<0.001

Visit 3 (Three Week)

0.84

2.62

1.78

<0.001

Table 2: Organoleptic score difference from the baseline and respective p-values

 

Graph 1 (left – Group A, and right – Group B): Graphical representation of mean organoleptic score changes across each visit.

 

Observation

The comparison between the placebo and active groups showed a significant reduction in oral malodor after 12 hours and three weeks. The p-value obtained from the repeated ANOVA Model was less than 0.001. Throughout the study, no adverse events were reported. Oral exams conducted at each visit revealed no abnormal conditions, indicating the absence of any safety concerns during the three-week use of the product.

 

Conclusion

The data and statistical assessment indicate that Gurunanda® Oil Pulling Rinse is both safe and effective in reducing oral malodor when used for a minimum of 2 minutes once a day. Additionally, it can be concluded that Gurunanda® Oil Pulling Rinse exhibits a significant reduction in malodor after 12 hours of use and helps with the maintenance and further improvement of malodor with continued usage.