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Background <p>The present study compares the anti-plaque efficacy of two commercially available dentifrices containing natural salivary enzymes in patients undergoing fixed orthodontic therapy.</p> Methodology <p>This prospective, parallel- arm, double-blind, randomized controlled trial included 54 participants undergoing fixed orthodontic therapy who were diagnosed with moderate to severe gingivitis and were randomly allocated into three groups (<i>n</i> = 18 per group). Group A received Dente 91<sup>®</sup> dentifrice, Group B received Enzycal 950™ dentifrice, and Group C served as the control group. Intergroup differences were analysed using one-way ANOVA followed by Bonferroni post hoc test. Within-group comparisons across multiple time points were assessed using repeated measures ANOVA with post hoc analysis, while paired t-test was used for comparisons between two-time intervals. Correlations between clinical and biochemical parameters were evaluated using Pearson’s correlation test. Primary outcomes included clinical parameters- Plaque Index (PI), Gingival Index (GI), and Bleeding on probing (BOP) which were assessed at baseline, 6, 12, and 24 weeks. The secondary outcomes involved evaluation of salivary biomarkers namely Advanced Oxidative Protein Products (AOPP) and Myeloperoxidase (MPO) levels which were estimated at baseline and at 24 weeks.</p> Results <p>Statistical analysis demonstrated significant differences between and within the three experimental groups at different time intervals with the level of significance set at <i>p</i> &lt; 0.05. Both enzyme-based dentifrices (Groups A and B) showed significantly greater improvements in PI, GI, and BOP compared to the Group C (control) (<i>p</i> &lt; 0.05). The salivary biomarkers, AOPP significantly decreased in Groups A and B (<i>p</i> = 0.0002), compared to Group C at 24th week study interval. Strong positive correlations were found between clinical indices (PI, GI, BOP) and AOPP (<i>p</i> &lt; 0.001) whereas MPO levels did not exhibit a significant correlation (<i>p</i> = 0.76) with any of the measured clinical parameters at study time points.</p> Conclusion <p>These findings suggest that enzyme-based dentifrices provide effective plaque control and may additionally contribute to reduction in oxidative stress, thereby offering dual benefits for patients undergoing orthodontic treatment. This clinical trial was prospectively registered on 21st July 2023 with the Clinical Trials Registry- India (CTRI/2023/07/055494).</p>

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Anti-plaque efficacy of two commercially available dentifrices in orthodontic patients. A randomized controlled clinical trial

  • 期刊论文

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  • 发表日期：

    2026年6月19日

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  • Krishna Nanaware,
  • Vinutha Bhat,
  • Vibha Acharya,
  • Arun Urala,
  • Jothi Varghese

摘要

Background

The present study compares the anti-plaque efficacy of two commercially available dentifrices containing natural salivary enzymes in patients undergoing fixed orthodontic therapy.

Methodology

This prospective, parallel- arm, double-blind, randomized controlled trial included 54 participants undergoing fixed orthodontic therapy who were diagnosed with moderate to severe gingivitis and were randomly allocated into three groups (n = 18 per group). Group A received Dente 91® dentifrice, Group B received Enzycal 950™ dentifrice, and Group C served as the control group. Intergroup differences were analysed using one-way ANOVA followed by Bonferroni post hoc test. Within-group comparisons across multiple time points were assessed using repeated measures ANOVA with post hoc analysis, while paired t-test was used for comparisons between two-time intervals. Correlations between clinical and biochemical parameters were evaluated using Pearson’s correlation test. Primary outcomes included clinical parameters- Plaque Index (PI), Gingival Index (GI), and Bleeding on probing (BOP) which were assessed at baseline, 6, 12, and 24 weeks. The secondary outcomes involved evaluation of salivary biomarkers namely Advanced Oxidative Protein Products (AOPP) and Myeloperoxidase (MPO) levels which were estimated at baseline and at 24 weeks.

Results

Statistical analysis demonstrated significant differences between and within the three experimental groups at different time intervals with the level of significance set at p < 0.05. Both enzyme-based dentifrices (Groups A and B) showed significantly greater improvements in PI, GI, and BOP compared to the Group C (control) (p < 0.05). The salivary biomarkers, AOPP significantly decreased in Groups A and B (p = 0.0002), compared to Group C at 24th week study interval. Strong positive correlations were found between clinical indices (PI, GI, BOP) and AOPP (p < 0.001) whereas MPO levels did not exhibit a significant correlation (p = 0.76) with any of the measured clinical parameters at study time points.

Conclusion

These findings suggest that enzyme-based dentifrices provide effective plaque control and may additionally contribute to reduction in oxidative stress, thereby offering dual benefits for patients undergoing orthodontic treatment. This clinical trial was prospectively registered on 21st July 2023 with the Clinical Trials Registry- India (CTRI/2023/07/055494).