Objective

This prospective, randomized, open-label, blinded endpoint assessor clinical study evaluated the efficacy and safety of the GuruNanda ® Compact Dental Water Flosser in improving gingival health, reducing dental plaque, and supporting overall oral hygiene over a 30-day period. The water flosser was assessed as an adjunct to twice-daily brushing with an ADA Accepted fluoride dentifrice, compared with twice-daily brushing alone.

The primary objective was to evaluate the change in gingivitis severity using the Loe and Silness Gingival Index from baseline to Day 15 and Day 30, including between-group comparisons. Secondary endpoints included dental plaque indices, oral health assessment, photographic assessments, global assessments, and safety/tolerability monitoring.

Process

A total 66 participants were randomized equally into two groups, with 33 participants per group.

Water Flosser Group: Participants brushed twice daily with an ADA Accepted fluoride dentifrice and additionally used the GuruNanda ® Compact Dental Water Flosser once daily in the morning for 30 days.

Control Group: Participants brushed twice daily with an ADA Accepted fluoride dentifrice for 30 days, without water flosser use.

Clinical evaluations were conducted at baseline/Day 0, Day 15, and Day 30. Parameters assessed included the Loe and Silness Gingival Index, Turesky Modified Quigley-Hein Plaque Index, Rustogi Modified Navy Plaque Index, Oral Health Assessment Tool, clinical photographs, investigator and participant global assessments, vital signs, and adverse event monitoring.

Results

The Water Flosser group demonstrated statistically significant improvements in gingival health, plaque control, oral cleanliness, gum swelling, and bleeding over the 30-day study period. Improvements generally favored the Water Flosser group compared with the control group.

The Loe and Silness Gingival Index decreased from 0.65 +/- 0.20 at baseline to 0.31 +/- 0.19 at Day 30 in the Water Flosser group, while the control group decreased from 0.75 +/- 0.30 to 0.50 +/- 0.21. The between-group comparison at Day 30 significantly favored the Water Flosser group.

The Turesky Modified Quigley-Hein Plaque Index decreased from 0.71 +/- 0.27 at baseline to 0.29 +/- 0.12 at Day 30 in the Water Flosser group, compared with a reduction from 0.86 +/- 0.29 to 0.52 +/- 0.25 in the control group. Between-group comparisons were statistically significant at Day 15 and Day 30.

The Rustogi Modified Navy Plaque Index demonstrated additional plaque reduction benefits. Whole-mouth RMNPI decreased from 0.15 +/- 0.06 to 0.06 +/- 0.03 in the Water Flosser group. Gingival margin RMNPI decreased from 0.44 +/- 0.16 to 0.17 +/- 0.08 at Day 30 

The Gingival Margin RMNPI decreased from 0.44 +/- 0.16 at baseline to 0.17 +/- 0.08 at Day 30 in the Water Flosser group, compared with a reduction from 0.40 +/- 0.15 to 0.24 +/- 0.13 in the control group. The between-group comparison was not significant at Day 15 but was statistically significant at Day 30, favoring the Water Flosser group.

Table 1. Clinical Outcomes Across Visits

 

Figure 1. Change in Gingival Index across study visits.

Figure 2. Change in Turesky Modified Quigley-Hein Plaque Index across study visits.

Figure 3. Change in Whole-Mouth RMNPI across study visits.

Figure 4. Change in Gingival Margin RMNPI across study visits.

Conclusion

The study showed that adding the GuruNanda ® Compact Dental Water Flosser to twice-daily brushing produced greater improvements in gingival health, plaque reduction, oral cleanliness, and gum-related outcomes compared with brushing alone. Investigator and participant global assessments favored the Water Flosser group at Day 30, with high levels of observed improvement in tooth cleanliness, tooth color, gum swelling, and gum bleeding.

The water flosser was observed to be safe and well tolerated. The final report indicated that use of the water flosser was not associated with adverse effects, and safety assessments included adverse event monitoring and vital signs throughout the study.

Regular use of the GuruNanda ® Compact Dental Water Flosser for 30 days, as an adjunct to twice-daily brushing with a fluoride dentifrice, demonstrated significant reductions in gingival inflammation and dental plaque compared with brushing alone. The study also showed improvements in oral cleanliness, gum swelling, gum bleeding. The product was well tolerated, supporting its use as an effective adjunctive oral hygiene device for improving gum health and plaque control.