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

OBJECTIVES: 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. MATERIALS AND METHOD: 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 6 months. 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 12 h 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. RESULTS: 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. CONCLUSIONS: 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.

Antimicrobial effects in oral microenvironments by a novel herbal toothpaste.

OBJECTIVE: This clinical study compared the antibacterial effects after brushing with a novel herbal toothpaste incorporating zinc [test] to a control fluoride toothpaste on anaerobic organisms, gram-negative bacteria and malodor bacteria of dental plaque, tongue scrapings and cheek surfaces. METHODS: This double-blind, two-cell study enrolled 44 adults [age range 19-63 years]. Subjects completed a 1-week washout and provided baseline oral samples i.e. dental plaque, tongue and cheek scrapings for microbiological analysis. Diluted samples for microbiological analyses were plated on agar to enumerate anaerobic organisms, gram-negative bacteria and malodor bacteria representing functional groups of organisms. Subjects were randomized to brush their teeth with either the test or control with the first brushing conducted under supervision in the dental clinic. Post-treatment samples were collected 12 h after 21 day hygiene with assigned toothpaste. After providing these samples, subjects brushed in the dental clinic with additional samples collected 4 h after brushing. Statistical analyses were conducted separately for each organism collected from each oral niche by t-test for within-treatment assessments and analysis of covariance (ANCOVA) for between-treatment comparisons. RESULTS: Treatment groups demonstrated no significant differences at baseline for anaerobic organisms, gram-negative bacteria and malodor bacteria in any oral niche (p > 0.05). The test demonstrated reductions between 42 and 68% for anaerobic bacteria in oral niches, 12 h after brushing with reductions increasing to 46-80%, 4 h after brushing. Similarly, the test demonstrated reductions between 49 and 61% for gram-negative bacteria of oral niches that increased to 54-69% at the 4 h post-brushing evaluation. Reductions in malodor organisms of 22-42% were noted 12 h after brushing that increased to 60-72%, 4 h after brushing. CONCLUSIONS: In comparison to control, brushing with a novel herbal toothpaste demonstrated significant reductions in functional bacterial groups from distinct oral niches 12 h after brushing with additional microbial reductions 4 h after brushing.

The effects of a novel herbal toothpaste on salivary lactate dehydrogenase as a measure of cellular integrity.

OBJECTIVE: Lactate dehydrogenase (LDH) is a critical intracellular enzyme responsible for anaerobic respiration in pyruvate metabolism which becomes detectable in extracellular spaces after cellular breakdown. This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, i.e., clove (Syzygium aromaticum), aloe vera (Aloe barbadensis), amla (Emblica officinalis), neem (Azadirachta indica), tulsi (Ocimum basillicum), and honey (from Apis mellifera), and 0.96% zinc (zinc oxide, zinc citrate) and 0.76% SMFP (1000 ppm F) in a calcium carbonate base formulated with natural ingredients (Ved Shakti, Colgate Palmolive India) and a fluoride toothpaste containing 0.76% SMFP (1000 ppm F) in a calcium carbonate base (Colgate Cavity Protection, Colgate Palmolive; henceforth control) on salivary LDH in conjunction with the assessments of dental plaque and gingivitis representing oral hygiene parameters. MATERIALS AND METHODS: This double-blind, two-cell study enrolled 70 adults (age range 20-59 years). Subjects completed a washout and provided baseline saliva samples for LDH analysis and clinical assessments of dental plaque and gingivitis using the Turesky Modification of Quigley-Hein and Loe-Silness methods respectively. Subjects were randomly assigned to brush their teeth with either the test or control. Post-treatment sample collection and clinical evaluations were conducted after 3 weeks, 6 weeks, and 12 week sof brushing with all assessments conducted 12 h after hygiene. Statistical analyses were conducted independently for each parameter by t-test for within treatment evaluation and analysis of covariance (ANCOVA) for between treatment comparisons. RESULTS: At baseline, treatment groups demonstrated no significant differences for LDH or dental plaque and gingival index scores. Brushing with the test demonstrated progressive reductions in salivary LDH, plaque and gingival index scores over the study duration in comparison to the control. The test demonstrated reductions in LDH of 9.5-15.4% over the study period in comparison to the control representing statistically significant effects (p < 0.05). The test also demonstrated reductions in dental plaque that ranged between 6.4 and 16.2% over the study period and gingivitis reductions that ranged between 8.2 and 23.8% representing statistically significant results (p < 0.05). CONCLUSIONS: Brushing with a novel herbal toothpaste demonstrated significant reductions in salivary LDH representing improvements in cellular integrity with concurrent reductions in dental plaque and gingivitis as compared to the control dentifrice. CLINICAL RELEVANCE: Salivary LDH measurements offer a non-invasive and objective measurement of mucosal cellular integrity complementing other evaluations and clinical assessments such as plaque and gingival index scores.

Bacteriological effects of dentifrices with and without active ingredients of natural origin.

Compounds of natural origin are increasingly used as adjuncts to oral hygiene. We have adopted four distinct approaches to assess the antibacterial activity of dentifrices containing natural active ingredients against oral bacteria in several test systems. Corsodyl Daily (CD), Kingfisher Mint (KM), and Parodontax fluoride (PF) were compared to a dentifrice containing fluoride (Colgate Cavity Protection [CCP]) and one containing triclosan (Colgate Total [CT]). The growth inhibitory and bactericidal potency of the formulations were determined for 10 isolated oral bacteria. Effects of single exposures of simulated supragingival plaques were then determined by epifluorescence and confocal microscopy, while the effects of repeated exposures were quantified by viable counting. Additionally, dense plaques, maintained in continuous culture, were repeatedly dosed, and the outcome was assessed by viable counting and eubacterial DNA profiling. The test dentifrices exhibited variable specificity and potency against oral bacteria in axenic culture. Of the herbal formulations, KM caused the largest viability reductions in simulated supragingival plaques, with CT causing the greatest reductions overall. Following single exposures, CD caused moderate reductions, while PF had no effect. After multiple dosing, all formulations significantly reduced numbers of total, facultative, and Gram-negative anaerobes, but only KM and CT caused greater reductions than the fluoride control. KM also reduced counts of streptococci (rank order of effectiveness: CT > KM > CCP > PF > CD). Marked changes in eubacterial DNA profiles were not detected for any herbal formulation in dense plaques, although KM markedly reduced viable counts of streptococci, in agreement with supragingival data. While both nonherbal comparators displayed antibacterial activity, the triclosan-containing formulation caused greater viability reductions than the herbal and nonherbal formulations.

Community-level assessment of dental plaque bacteria susceptibility to triclosan over 19 years.

BACKGROUND: Triclosan is a broad-spectrum antimicrobial agent used in toothpaste to reduce dental plaque, gingivitis and oral malodor. This community-level assessment evaluated the susceptibility of dental plaque bacteria to triclosan in samples collected over 19 years. METHODS: A total of 155 dental plaque samples were collected at eleven different times over 19 years from 58 adults using 0.3% triclosan, 2% copolymer, 0.243% sodium fluoride toothpaste and from 97 adults using toothpaste without triclosan. These included samples from 21 subjects who used triclosan toothpaste for at least five years and samples from 20 control subjects. The samples were cultured on media containing 0, 7.5 or 25 µg/ml triclosan. Descriptive statistics and p values were computed and a linear regression model and the runs test were used to examine susceptibility over time. RESULTS: Growth inhibition averaged 99.451% (91.209 - 99.830%) on media containing 7.5 µg/ml triclosan and 99.989% (99.670 - 100%) on media containing 25 µg/ml triclosan. There was no change in microbial susceptibility to triclosan over time discernible by regression analysis or the runs test in plaque samples taken over 19 years including samples from subjects using a triclosan-containing dentifrice for at least five years. CONCLUSIONS: This community-level assessment of microbial susceptibility to triclosan among supragingival plaque bacteria is consistent with the long-term safety of a 0.3% triclosan, 2% copolymer, 0.243% sodium fluoride dentifrice.