Clinical Evaluation of GuruNanda® Whitening Mouthwash with Enzymes versus Active Comparator
A randomized, double-blind clinical evaluation of enzymatic tooth whitening efficacy
Objective
The objective of this clinical study was to evaluate the whitening efficacy and safety of GuruNanda® Whitening Mouthwash with Enzymes compared with an active comparator (peroxide-free whitening mouthwash) and a placebo control. The study assessed improvements in tooth shade, reduction of surface stains, and prevention of new stain formation following regular use.
The formulation contains enzymatic whitening agents including papain (derived from papaya) and glucose oxidase, designed to gently degrade protein-based stains and oxidize discoloration without causing enamel irritation or sensitivity.
Process
This single-center, randomized, double-blind, placebo-controlled clinical study enrolled 120 adult participants meeting predefined inclusion and exclusion criteria. Subjects were randomized equally into three groups (n = 40 per group):
- Group A (Active): GuruNanda® Whitening Mouthwash with Enzymes
- Group B (Comparator): Peroxide-free Whitening Fresh Breath Mouthwash
- Group C (Control): Non-enzymatic flavored placebo mouthwash
Participants used 20 mL of the assigned mouthwash twice daily for six weeks. Clinical evaluations were conducted at baseline (screening), Week 2, Week 4, and Week 6.
The primary efficacy endpoints included change in tooth shade measured using the VITA shade scale and reduction in surface stain index. Secondary endpoints included prevention of new stain formation, compliance, and tolerability. Safety was evaluated through oral examinations, hematology, biochemistry, and adverse event monitoring. Statistical analysis was performed using paired t-tests and ANOVA, with statistical significance defined as p < 0.05.
Results
Table 1. Mean Change in Tooth Shade (VITA Scale) Across Study Visits
| Group | Baseline Mean ± SD |
Week 2 | Week 4 | Week 6 | Δ from Baseline | p-Value vs Placebo |
|---|---|---|---|---|---|---|
| GuruNanda® Whitening Mouthwash with Enzymes | 5.9 ± 2.2 | 6.6 ± 2.2 | 7.2 ± 2.1 | 7.7 ± 2.1 | 1.8 | < 0.001 |
| Peroxide-free Whitening Mouthwash | 6.3 ± 2.7 | 6.6 ± 2.8 | 7.0 ± 2.9 | 7.2 ± 2.8 | 0.9 | < 0.001 |
| Placebo | 7.1 ± 2.4 | 7.2 ± 2.4 | 7.3 ± 2.5 | 7.3 ± 2.5 | 0.2 | — |
Table 2. Mean Percentage Reduction in Surface Stain Index
| Group | Baseline Stain Index Mean ± SD |
Week 6 Mean ± SD |
% Reduction | p-Value vs Placebo |
|---|---|---|---|---|
| GuruNanda® Whitening Mouthwash with Enzymes | 6.0 ± 1.1 | 3.6 ± 0.6 | 40.0% | < 0.001 |
| Peroxide-free Whitening Mouthwash | 5.8 ± 0.7 | 4.3 ± 0.5 | 25.8% | < 0.001 |
| Placebo | 5.7 ± 1.0 | 5.4 ± 0.9 | 5.2% | — |
Figure 1. Comparative improvement in mean tooth shade (VITA scale) from baseline to Week 6, demonstrating consistently greater whitening efficacy with GuruNanda® Whitening Mouthwash with Enzymes.
Figure 2. Percentage reduction in surface stain index after six weeks of treatment, showing superior stain removal with the enzyme-based formulation compared to comparator and placebo.Observation
GuruNanda® Whitening Mouthwash with Enzymes demonstrated superior whitening performance and stain reduction compared with both the active comparator and placebo. Visible improvements were observed as early as Week 2, with continued gains through Week 6.
No evidence of enamel irritation, ulceration, or sensitivity was reported. Subjects noted improved mouthfeel and freshness with the enzyme-based formulation. Compliance was 100%, and laboratory values remained within normal limits throughout the study.
Conclusion
This clinical evaluation confirms that GuruNanda® Whitening Mouthwash with Enzymes effectively improves tooth shade and reduces surface stains with regular use. The enzymatic, peroxide-free formulation provides a gentle and well-tolerated whitening alternative suitable for long-term daily oral care.