A randomized clinical study to examine the oral hygiene efficacy of a novel herbal toothpaste with zinc over a 6-month period.

Abstract

This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, that is, clove (Syzgium Aromaticum), aloe vera (Aloe Barbadensis), amla (Emblica Officinalis), neem (Azadirachta Indica), tulsi (Ocimum Basillicum) and honey (from Apis Mellifera) along with zinc salts and fluoride in comparison with a dentifrice formulated with fluoride alone on dental plaque and gingivitis over a 6-month period. One hundred and eighty (180) subjects with mean plaque index scores greater than 1.5 (Turesky Modified Quigley Hein Plaque Index) and gingival index scores >1.0 (Loe and Silness gingival index) in good general health and who met other study criteria were enrolled in the clinical study. Subjects were evaluated for plaque and gingival index scores and were randomly assigned to perform twice-daily oral hygiene with either the test or the control toothpaste for the next 6months. One hundred and fifty (150) subjects [test toothpaste (n=72) and control toothpaste (n=78)] completed the 6-month clinical study with evaluable data. Post-treatment assessments identical to baseline were conducted after 3-month and 6-month use of an assigned product after subjects refrained from oral hygiene for 12h prior to each evaluation. Comparisons of the treatment groups with respect to baseline-adjusted gingival, plaque, and bleeding index scores at the follow-up examinations were performed using analyses of covariance (ANCOVA). All statistical tests of hypotheses were two-sided and employed a level of significance of p<0.05. No significant intergroup differences were noted between treatment groups for age and gender by two-sample t-test and chi-square analyses, respectively (p>0.05). Furthermore, the treatment groups demonstrated no differences at baseline for plaque, gingival and bleeding index scores by a two-sample t-test (p>0.05). At 3-month and 6-month examination, the test toothpaste exhibited progressive reductions in plaque, gingival and bleeding scores as compared to control toothpaste as showed by ANCOVA (p<0.001). In comparison with the control, the test demonstrated reductions in 23.5%, 25.6%, and 73.3% for dental plaque, gingival index and bleeding index outcomes, respectively, at the final visit. Reductions in the frequencies of sites with higher clinical scores were noted over the study with more sites registering improvements in the test group than in the control group. Routine oral hygiene with the test toothpaste formulated with herbal ingredients and zinc demonstrated a clinical adjunctive improvement in oral hygiene and parameters of gingival health as compared to brushing with a fluoride toothpaste.