Evaluation of Safety and Efficacy of GuruNanda Oil Pulling Rinse in Compared to Alcohol-Based Mouthwash and Placebo for Oral Hygiene Support in Adults: A Randomized, Double-Blind, Active and Placebo-Controlled Parallel Group Clinical Trial

Objectives:

Primary Evaluations:
• Assess the test product's effectiveness compared to an alcohol-based mouthwash and placebo in promoting gum health.
Secondary Evaluations:
• Evaluate the test product's effectiveness compared to the alcohol-based mouthwash and placebo in addressing oral malodor and oral dryness.
• Assess the test product's effectiveness compared to the alcohol-based mouthwash and placebo in enhancing teeth whitening.
• Evaluate the safety and tolerability of the test product.
Process:
A 2-week, single-center, randomized, double-blind, placebo-controlled trial was conducted, involving 66 subjects. Subjects were randomly assigned to receive either the test product, comparator product, or placebo. Safety and efficacy evaluations, including assessments of gingival index, plaque index, saliva microbial analysis, oral malodor, reduction in oral dryness, and teeth shade, were carried out at the beginning and end of the study by trained professionals. Statistical analysis was performed to determine the significance of observed changes.

Results:

Modified Gingival Index (MGI)

	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	21	20	21	0.015
Mean reduction in MGI score	2.7	-1.4	-1.1

Table 1: Mean reduction in Modified Gingival Index (MGI) scores from baseline within each group: Test, Active Comparator, and Placebo Group

 

Plaque Index (PI)

	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	21	20	21
Mean % reduction in PI score	30.6	15.5	2.7	<0.001

Table 2: Mean % reduction in Plaque Index (PI) scores from baseline within each group: Test, Active Comparator, and Placebo Group

Clinical Oral Dryness Scores (CODS)

	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	21	20	21	<0.001
Mean improvement in CODS	0.9	-1.9	-1.0

Table 3: Improvement in Clinical Oral Dryness Scores from baseline within each Group: Test, Active Comparator, and Placebo Group

Organoleptic Score (OS)

	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	21	20	21	<0.001
Mean Improvement in OS	1.52	0.75	-0.14

Table 4: Improvement in Organoleptic Scoring from baseline within each Group: Test, Active Comparator, and Placebo Group

VITA Tooth Shade Scale

Attributes	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	21	20	21
Mean (Improvement in tooth shade)	0.9	-0.3	0.3	0.011

Table 5: Improvement in VITA Shade Scale from baseline within each Group: Test, Active Comparator, and Placebo Group

 

Microbial Reduction

	Test	Comparator (Alcohol based Mouthwash)	Placebo	p-Value
Number of subjects (N)	8	5	6
Mean (% CFU reduction of gram-negative bacteria)	24.9	22.1	11.0	0.004

Table 6: Comparative Reduction of Gram Negative Bacterial CFUs Across Test, Active Comparator, and Placebo Groups

Conclusions:

In conclusion, the outcomes of this clinical trial showcase the superior effectiveness of GuruNanda Oil Pulling Rinse compared to both an alcohol-based mouthwash (considered as the active comparator) and a placebo across various aspects of oral hygiene.
The Modified Gingival Index (MGI) revealed a significant reduction in scores within the GuruNanda group when compared to both the active comparator and placebo. Likewise, the Plaque Index (PI) demonstrated notable enhancements in the GuruNanda group, surpassing both the active comparator and placebo, with statistically significant p-values indicating the efficacy of GuruNanda Coco-Mint Oil Pulling Rinse in enhancing overall gum health.
Furthermore, the Clinical Oral Dryness Scores (CODS), Organoleptic Score (OS), and VITA Tooth Shade Scale consistently indicate the better performance of GuruNanda, with significant enhancements observed across all three parameters in comparison to both the active comparator and placebo groups. These findings suggest that GuruNanda product helps improve other areas of oral hygiene, such as dry mouth, malodor, and teeth whitening.
The microbial reduction analysis showcased a substantial decrease in Gram-negative bacterial colony-forming units (CFUs) in the GuruNanda group compared to the other groups, illustrating its potential in combating oral microbial pathogens.
Overall, these results underscore the safety and efficacy of GuruNanda Oil Pulling Rinse as a compelling option for adults seeking effective oral hygiene support, particularly for those concerned about gum and teeth health.