Safety and Efficacy of GuruNanda® Breath Harmonizer Mouthwash in Reducing Oral Malodor and Improving Oral Health
Randomized, double-blind, placebo-controlled clinical study (N = 64; 3-week duration)
Objective
The objective of this randomized, double-blind, placebo-controlled clinical study was to evaluate the efficacy and safety of GuruNanda® Breath Harmonizer Mouthwash in reducing oral malodor and improving oral hygiene parameters such as plaque and tartar accumulation over a three-week period, in accordance with ADA guidelines.
Process
A total of 64 healthy male and female volunteers aged 18 years and above were enrolled and randomized into two groups (n = 32 each):
- Group 1 (G1): GuruNanda® Dual-Barrel Mouthwash
- Group 2 (G2): Placebo formulation
Participants underwent a 3-day washout period using a standard toothbrush and toothpaste provided by the sponsor. Assessments were performed at baseline, 15 minutes post-use, 12 hours, and 3 weeks. Three trained odor judges independently evaluated oral malodor using a 0–10 grading scale (higher = stronger malodor). Visual assessments for plaque, tartar, and oral tissue health were conducted by a qualified grader. All procedures adhered to Good Clinical Practice (GCP) and the Declaration of Helsinki.
Results
A statistically significant reduction in oral malodor scores was observed in the GuruNanda® group across all timepoints (p < 0.01), with mean score decreasing from 6.06 ± 0.83 at baseline to 0.00 ± 0.00 at 3 weeks. The placebo group showed minimal initial improvement but an increase in malodor by week 3 (6.91 ± 0.64). Plaque and tartar indices decreased significantly in the GuruNanda® group but increased in the placebo group, confirming superior cleaning and deodorizing efficacy. No adverse effects or oral tissue abnormalities were reported.
Table 1. Mean Oral Malodor Scores Over Time
| Timepoint | GuruNanda (G1) | Placebo (G2) | % Reduction (G1) | % Reduction (G2) | p-value |
|---|---|---|---|---|---|
| Baseline | 6.06 ± 0.83 | 6.01 ± 0.71 | — | — | — |
| 15 min | 1.00 ± 0.00 | 2.02 ± 0.08 | −84 % | −66 % | < 0.01* |
| 12 hr | 4.14 ± 0.87 | 5.94 ± 0.70 | −32 % | −1 % | < 0.01* |
| 3 weeks | 0.00 ± 0.00 | 6.91 ± 0.64 | −100 % | 15 % | < 0.01* |
*Significant difference between groups.
Table 2. Mean Plaque Scores at Different Time Intervals
| Group | Timepoint | Mean | SD | Mean Diff vs Baseline | Within Treatment p | Between Treatment p |
|---|---|---|---|---|---|---|
| G1 (n = 32) | Baseline | 2.00 | 0.25 | — | — | — |
| G1 | After First Use | 1.98 | 0.20 | −0.02 | 0.74 | 0.32 |
| G1 | 12 Hours | 2.00 | 0.25 | 0 | 1 | 1 |
| G1 | 3 Weeks | 1.16 | 0.27 | −0.84 | < 0.01* | < 0.01* |
| G2 (n = 32) | Baseline | 1.81 | 0.69 | — | — | — |
| G2 | After First Use | 1.81 | 0.69 | 0 | 1 | — |
| G2 | 12 Hours | 1.81 | 0.69 | 0 | 1 | — |
| G2 | 3 Weeks | 2.19 | 0.70 | +0.38 | < 0.01* | — |
Table 3. Mean Tartar Scores at Different Time Intervals
| Group | Timepoint | Mean | SD | Mean Diff vs Baseline | Within Treatment p | Between Treatment p |
|---|---|---|---|---|---|---|
| G1 (n = 32) | Baseline | 1.59 | 0.56 | — | — | — |
| G1 | After First Use | 1.58 | 0.56 | −0.02 | 0.74 | 0.32 |
| G1 | 12 Hours | 1.59 | 0.56 | 0 | 1 | 1 |
| G1 | 3 Weeks | 1.05 | 0.15 | −0.55 | < 0.01* | < 0.01* |
| G2 (n = 32) | Baseline | 1.66 | 0.48 | — | — | — |
| G2 | After First Use | 1.66 | 0.48 | 0 | 1 | — |
| G2 | 12 Hours | 1.66 | 0.48 | 0 | 1 | — |
| G2 | 3 Weeks | 2.02 | 0.39 | +0.36 | < 0.01* | — |
*Significant change from baseline or significant difference between groups.
Observation
The GuruNanda® Breath Harmonizer Mouthwash demonstrated rapid and sustained efficacy in reducing oral malodor, plaque, and tartar levels. Reduction in malodor was evident within 15 minutes of use and persisted for up to three weeks. The placebo group did not show meaningful improvement. Clinical evaluations revealed no irritation, tissue changes, or adverse effects, confirming excellent tolerability and safety. These findings indicate that the GuruNanda® Breath Harmonizer provides both immediate and long-term deodorizing and oral hygiene benefits for daily use.
Conclusion
This randomized, double-blind clinical trial established that GuruNanda® Breath Harmonizer Mouthwash is a safe and effective formulation for reducing oral malodor and improving oral hygiene. Its dual-barrel mechanism significantly lowered malodor, plaque, and tartar without causing adverse reactions. Regular use promotes fresher breath, clean teeth, and healthy oral tissue, making it a promising addition to everyday oral care routines.