|Year : 2020 | Volume
| Issue : 4 | Page : 296-303
Evaluation of efficacy and safety of two herbal dentifrices in dental caries, toothache, and oral hygiene: A randomized active controlled prospective clinical study
Satyendra Kumar1, Vinayak Rao2, Sanjay Devasthale1, Arun Gupta1
1 Dabur Research & Development Centre, Dabur India Limited, Ghaziabad, India
2 MS Clinical Research Pvt. Ltd., Bangalore, India
|Date of Submission||07-Oct-2020|
|Date of Decision||31-Dec-2020|
|Date of Acceptance||02-Jan-2021|
|Date of Web Publication||11-Feb-2021|
Mr. Satyendra Kumar
Dabur Research & Development Centre, Dabur India Limited, Plot No. 22, Site IV, Sahibabad, Ghaziabad, 201010, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Objective: The use of herbal remedies has assumed a global dimension. A shift of preferences toward herbal ingredients in the oral care segment is gaining momentum. The current study is aimed at assessing the efficacy and safety of two herbal active toothpastes Dabur Red Toothpaste (DRT) and Dabur Babool Toothpaste (DBT) in dental caries, toothache, plaque, and oral hygiene in comparison to a chemical active-based marketed dental cream (MDC). Materials and Methods: The study was an open-label, randomized, controlled, parallel-group, monocentric, efficacy, and safety study. One hundred and twenty healthy male and female subjects between 12 and 65 years who satisfied inclusion and exclusion criteria were randomized equally (1:1:1) into three groups. Each subject was assigned to use one of the three randomized study products, which was to be used twice daily for 24 weeks. Efficacy was assessed on the basis of changes in parameters such as caries, plaque, gum bleeding, halitosis, dental stains, oral hygiene, toothache, and salivary pH; and the subject’s self-assessment of bad breath, toothache, plaque/ yellowish or sticky deposit on the teeth, and the mouth feel of toothpastes. Safety was assessed on the basis of monitoring of adverse events from baseline study completion. Results: Reduction in gum bleeding, halitosis (bad breath), microbial growth, and improvement in oral hygiene were seen in all the tested toothpastes. A significant reduction in tooth pain, stain intensity, and stain area was also observed. No deterioration in the condition of caries was observed in any of the groups. The products also helped maintain the salivary pH. None of the reported AE that was assessed was found to be related to the study treatments, except swelling (gums) and boils (tongue), one each in the DRT and MDC groups, which were resolved on their own without any sequelae. Conclusion: All the tested toothpastes were effective and safe in dental conditions such as dental caries, toothache, and oral hygiene and they were assessed to be well tolerated and safe.
Keywords: Babool toothpaste, dental caries, oral hygiene, red toothpaste, toothache
|How to cite this article:|
Kumar S, Rao V, Devasthale S, Gupta A. Evaluation of efficacy and safety of two herbal dentifrices in dental caries, toothache, and oral hygiene: A randomized active controlled prospective clinical study. J Indian Sys Medicine 2020;8:296-303
|How to cite this URL:|
Kumar S, Rao V, Devasthale S, Gupta A. Evaluation of efficacy and safety of two herbal dentifrices in dental caries, toothache, and oral hygiene: A randomized active controlled prospective clinical study. J Indian Sys Medicine [serial online] 2020 [cited 2021 Mar 9];8:296-303. Available from: https://www.joinsysmed.com/text.asp?2020/8/4/296/309131
| Introduction|| |
Dental care is an essential part of personal hygiene and is considered just as important as having a balanced diet and getting physical exercise. Brushing and flossing are crucial activities that affect oral health. A healthy mouth helps people eat well, avoid pain and tooth loss, and feel good.
The mouth has a resident microflora that develops naturally, and which has a characteristic composition. Owing to differences in local environment conditions, the microflora of mucosal surfaces may differ in composition from that of dental plaque. For similar reasons, the plaque microflora varies in composition at distinct anatomical sites on the tooth, for example, in fissures, on approximal surfaces, and in the gingival crevice. The resident microflora of a site is of benefit to the host by acting as part of the host defenses and by preventing colonization by exogenous (and often pathogenic) microorganisms.
The early colonizers of the tooth surface include members of the genera Streptococcus, Actinomyces, Haemophilus, Neisseria, and Veillonella., These bacteria adhere to the acquired enamel pellicle by specific and nonspecific molecular interactions between adhesions on the cell and receptors on the surface., Subsequent bacteria of the same or different species are able to adhere not only to pellicle but also to the preattached cells (coaggregation)., Once attached, cells grow on the tooth surface, and micro-colonies are observed eventually; especially at stagnant sites, the combination of bacterial multiplication with further adhesion and co-aggregation produces confluent growth. Thus, dental plaque develops naturally on the tooth surface and forms part of the host defenses of the mouth by acting as a barrier to colonization by exogenous microorganisms. This barrier effect has been termed “colonization resistance,” and it can be broken by, for example, the long-term use of broad-spectrum antibiotics. Under such circumstances, there can be overgrowth by nonresident microorganisms (especially yeasts and enteric bacteria) and the emergence of antibiotic-resistant strains. The central role played by bacteria colonizing the teeth in the initiation of dental caries and periodontal diseases, including inflammation, redness, and bleeding of gums, starts progressing.
Oral care is emphasized not only for cosmetic purpose but also for health care. Ayurveda recommends a comprehensive regimen for the preservation of health as a code of the health conduct, namely “Svasthavritta.” It includes the daily code of health conduct (Dinacharya), conduct for the night (Ratricharya), and conduct in relation to various seasons (Ritucharya). Details about lifestyle, diet, exercise, and personal and social hygiene have also been described. Sushruta has given great importance to daily dental hygiene practices. Ayurvedic literature suggests several medicinal herbs, which can be used for cleansing teeth as well as massaging of gums.,
Recently, an increasing number of commercial products are available that contain newer ingredients, which are positioned either directly or through inference as providing added therapeutic or cosmetic benefits compared with conventional toothpastes. Recent years have seen an interest in products that are composed of natural ingredients. DRT and DBT (Mfd: Dabur India Limited) are herbal toothpastes that contain extracts derived from herbs such as Tomar beej (Zanthoxylum armatum), Shunti (Zingiber officinale), Lavang oil (Oil of Syzygium aromaticum), Pudina Satva (Mentha piperita), Babool (Acacia arabica) etc, which are used traditionally in oral care. The current study aimed at assessing the efficacy and safety herbal toothpastes in comparison to a marketed chemical-based dental cream in terms of changes in dental caries, relief from toothache, and reduction in plaque and oral hygiene in comparison to baseline. It also aimed at establishing the superiority of one of the test products, at a defined time point, in comparison to the other test products.
| Materials and Methods|| |
The study was an open-label, randomized, controlled, parallel-group, monocentric, efficacy, and safety study conducted at MS Clinical Research Private Limited, Bangalore, Karnataka. The study was initiated after taking necessary regulatory approvals and was registered with the Clinical Trial Registry of India with No. CTRI/2014/11/005212 on 20 November 2014.
DRT is prepared from the following ingredients: Maricha (Piper nigrum), Pippali (Piper longum), Shunthi (Zingiber officinale), Tomar beej (Zanthoxylum armatum), Lavang oil (Oil of Syzygium aromaticum), Karpoor (Cinnamomum camphora), Pudina Satva (Mentha piperita), and Gairic Powder (Red Ochre), along with permitted excipients and preservatives.
DBT contains Babool (Acacia arabica) extract, clove oil (oil of Syzygium aromaticum flower bud) along with excipients and preservatives.
MDC contains ingredients such as calcium carbonate, sodium monoflurophosphate, sodium lauryl sulfate, silica, carrageenan, triclosan, flavor etc.
Subjects in the age group of 12 to 65 years in general good health and oral health, having an ICDAS score of 2 and 3 pertaining to dental caries, and having extrinsic dental stains and bad oral hygiene were included. Only those willing to give voluntary written informed consent, those agreeing to come for regular follow-up, and those who had not participated in a similar investigation in the past four weeks were included in the current study.
Subjects with a known history or present condition of hypersensitivity to any toothpaste, the use of antibiotics, antimicrobial, analgesic medications, mouthwash, or desensitizing toothpaste during the previous one month, any history of periodontal therapy by surgical interventions, history of dentine hypersensitivity treatment, orthodontic treatment with fixed appliances, any removable device such as a removable partial denture or orthodontic retainer, the presence of any fixed appliance, large or defective restorations, cracked enamel or caries on the hypersensitive tooth, history of smoking or smokeless tobacco products; subjects having moderate to severe dentine hypersensitivity; subjects having intrinsic dental stains; subjects having abnormal frenum attachment; subjects who were pregnant, lactating, or nursing, subjects having a severe level of calculus and/ tartar, any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease, or history of alcoholism, HIV + status, hepatitis, or any other serious medical illness were excluded.
At baseline, the subjects were trained on modified Bass Brushing Technique by using artificial denture and video. Thereafter, they were randomized equally and were asked to use the assigned toothpaste twice daily (morning and night) for 24 weeks. The subjects were harmonized with the same brand of toothbrush and instructed to cover 15mm length of the filament section of the toothbrush with the toothpaste and to brush for 2–3min. The subjects were instructed to fill the time of toothpaste application in the appropriate date/ day column in the diary. All the subjects were closely monitored for any adverse events, starting from baseline till the end of the study visit. The subjects were also instructed to report any irritation experienced to the investigator/ study coordinator during the product usage on their visit to the site as well as to record the same in the subject diary provided.
The study was conducted over a period of 24 weeks, with five follow-up visits: Visit I (screening visit), Visit 2 (baseline visit, day 1), Visit 3 (day 30, week 4), Visit 4 (day 87, week 12), and Visit 5 (day 171, week 24). The first subject enrollment at site was on 02 December 2014, and the date of last follow-up at site was 16 June 2015.
Assessment Efficacy Parameters
Optimum protection of dental caries for relief from toothache by VAS score, assessment of dental plaque by Turesky Modification of the Quigley-Hein Plaque Index (TQMPI),, gum bleeding by Bleeding on Marginal Probing Index (BOMP), halitosis by organoleptic scoring, Lobene stain index, oral hygiene index, and salivary pH. Subjects’ self-assessment for various sensory parameters was also included.
Assessment of Safety Parameters
Assessment for site application reaction was done by investigator assessment of gingiva, oral mucosa, and lips. This was done based on the following parameters: erythema, inflammation, ulceration, pustules, allergic reactions, and any others at all the visits.
The subjects were also asked to observe the changes in application site and to grade any reactions observed based on the following parameters: redness, swelling, boils, ulcer-like reactions, and any others at all the visits.
A descriptive statistical analysis was carried out in the present study. Results on continuous measurements were presented as mean ± SD, and results on categorical measurements were presented in frequency expressed as number (%). Significance was assessed at a 5% level of significance. A Z proportion test was performed to find the significance of change in the proportion of outcome from baseline to final visit on categorical type, such as the subject’s assessment. A 95% Confidence Interval was computed to find the significant features. Paired t test was performed to find out efficacy in comparison to baseline on continuous scales such as dermatological assessment and instrumental assessment. ANOVA test was performed to find out the significant difference between the groups.
| Results|| |
A total of 120 subjects were screened for eligibility. There were no screen failures, and all the 120 subjects were enrolled and randomized equally (40 each) into either of the study groups. The groupwise distribution of subjects and the demographic details are shown in [Table 1]. There was no significant difference between the average ages of subjects in the study groups [Table 1].
Assessment of Efficacy
Effect on Dental Caries
Caries assessment was graded on the basis of the International Caries Detection and Assessment System (ICDAS). The condition of caries remained same over the study period. There was no deterioration in the condition of caries in any of the three study groups [Table 2].
Effect on Salivary pH
The pH remained near neutral value throughout the study in all three study groups.
Effect on Gum Bleeding
Gum bleeding score was assessed by using BOMP. The improvement in bleeding was observed from the 12th week onward in all three study groups. DRT and MDC showed a statistically significant improvement in gum bleeding at the 12th and 24th week assessment over baseline, whereas DBT showed statistically significant improvement at the 24th week assessment. At the end of the study, 22.58%, 15%, and 14.29% improvement in bleeding, respectively was observed with DRT, DBT and MDC [Figure 1].
Evaluation of Halitosis
Halitosis or bad breath may arise due to poor oral hygiene, eating habits etc. Changes in halitosis were assessed on the basis of the organoleptic scoring scale (0 = Odor cannot be detected, 1 = Questionable bad odor, barely detectable, 2 = Slightly bad odor, exceeds threshold of bad odor recognition, 3 = Bad odor is definitely detected, 4 = Strong bad odor, 5 = Very strong bad odor).
A significant and progressive improvement in halitosis was observed at the fourth week assessment in all the study groups in comparison to baseline. At the end of the study, 35.64% improvement in DRT, 35.81% improvement in DBT, and 46% improvement in MDC for halitosis score were, respectively, observed [Figure 2].
Effect on Oral Hygiene Index
Oral Hygiene Index is a very important parameter, which includes reduction of debris and calculus. An improvement in oral hygiene index was noticed from the fourth week assessment onward, and it was found to be progressive and statistically significant till the end of the study in all the three study groups. At the end of the study, 35.74%, 25.11%, and 22.27% improvement in oral hygiene index was observed with DRT, DBT, and MDC, respectively [Figure 3].
Effect on Tooth Pain
Reduction in VAS scoring for tooth pain was noticed at all the evaluated time points and was found to be statistically significant at 12th and 24th week assessments in comparison to baseline in all the study groups. At the end of the study, reduction in tooth pain was found to be highest (70.12%) with DRT when compared with DBT (63.93%) and MDC (55.46%) [Figure 4].
Effect on Lobene stain index (Stain Intensity)
Reduction in the dental stain intensity was noted to be progressive and statistically significant at all the time points of the study in comparison to baseline, in DRT and MDC. DBT showed a statistically significant improvement at 12th and 24th week assessments in comparison to baseline. At the end of the study, 29.31%, 23.72%, and 22.58% improvement was observed with MDC, DBT, and DRT, respectively [Figure 5].
Effect on Lobene stain index (Stain Area)
A statistically significant reduction in stain area was observed at all the evaluated time points of the study in comparison to baseline for DRT and MDC. DBT showed a statistically significant improvement from the 12th week onward. At the end of the study, 29.85%, 29.31%, and 18.52% improvement in stain area was observed with DRT, MDC, and DBT, respectively.
Effect on Total Stain
DRT and MDC showed a statistically significant improvement at all time points of evaluation of total significant dental stain in comparison to baseline, whereas DBT showed a statistically significant improvement from the 12th week onward. At the end of the study, MDC showed the highest improvement in total dental stain, followed by DRT and DBT [Table 3].
DBT showed a statistically significant reduction in plaque condition at the end of the study in comparison with baseline; however, no improvement was observed in DRT and MDC.
A statistically significant reduction in microbial growth was observed at the end of the study in DBT and DRT. The reduction in microbial growth was also noticed in MDC; however, it was not statistically significant.
Subjective Assessment of Efficacy
At the end of the study, a significant proportion of the subjects in all study groups did not experience any irritation (sensation such as itching, burning, redness) or dryness of mouth after brushing. None of the population experienced any pungency or discomfort or perceived any grittiness after brushing at the end of the study [Table 4].
Assessment of Safety
Assessment of incidence of adverse events
Adverse Events (AE) were reported in 21 subjects. Of these, five subjects were in the DBT Group, seven subjects were in the DRT Group, and nine subjects were in the MDC Group. The common AE reported were fever, cough, cold, body pain, gum swelling, boils (Tongue) etc. However, none of the AE was assessed to be related to the study treatment, except swelling (Gums) and boils (Tongue), which is possible but the same were resolved without sequelae.
All the tested products were assessed to be overall well tolerated and safe. The minimal reactions of erythema, ulcer, and pustules subsided eventually at the end of the study. The mild severity and the fact that it did not require any medical intervention as per dermatological evaluation strengthened the fact that the products were well tolerated and safe.
| Discussion|| |
Dental caries is a long-standing condition and it develops over a period of time. It is not possible to reverse the caries but with proper hygiene and care of dental enamel, it can be prevented from further progression. Salivary pH is an important factor in determining the prevalence of caries. A drop in the pH increases the risk of de-mineralization whereas an increase in the pH will decrease de-mineralization and caries. Fluoridated toothpastes are generally preferred to prevent dental caries, as they help in enamel protection. However, herbal ingredients with known antibacterial properties may help in controlling the bacterial growth that hastens caries formation considering the role of oral microbial flora, oral pH in caries formation. Significant reduction in bacterial growth and plaque formation and maintenance of oral pH in DRT and DBT groups also suggest the activity of these formulations pertaining to dental caries.
The reduction in DRT and DBT may be attributed to the astringent properties of ingredient herbs. Gum bleeding is a major sign of gingivitis and it could be graded from bleeding on probing to spontaneous bleeding. A further reduction in BOMP indicates the gum-strengthening effect of trial formulations. Arresting gum bleeding will prevent further progression of gingivitis to periodontitis.
Halitosis is usually the result of sulfur-containing food stuffs and hygiene habits adopted by an individual. However, some people may be more prone to having oral bad breath. Various herbs have antibacterial activity against different species of diverse oral microflora. DBT and DRT have shown significant efficacy on halitosis.
Oral Hygiene Index includes scoring of debris and calculus. DRT and DBT show better results than MDC. The antibacterial property of ingredient herbs contributes predominantly to the reduction in debris scoring. The reduction in calculus is possible only by scaling methods, as calculus is a hardened material on dental enamel. Dental plaque is a white/ pale yellow biofilm on the teeth surface. It can give rise to gum diseases and caries. Microbial growth evaluation was performed based on the quality of plaque. Reduction in microbial growth eventually reduces dental plaque. Plaque is also a precursor of dental calculi. The efficacy of DRT and DBT in plaque removal suggests its benefits in preventing calculus formation, improving oral hygiene, and reducing halitosis as well.
Tooth pain may arise due to caries, infection, and dental injuries. According to the numeric scale mentioned for tooth pain, a decrease in the mean score is a sign of improvement. A significant reduction in tooth pain was comparable in all the groups. However, the DRT group was better than the DBT group followed by MDC.
Extrinsic dental stains are manageable by proper brushing and good oral hygiene. A consistent reduction in stain-related parameters indicates the efficacy of DRT and DBT in improving oral hygiene and removing extrinsic stains.
Subjective assessment of safety and efficacy also suggests that the products DRT and DBT are safe and beneficial in view of good compliance and overall impression.
It is estimated that 70% to 80% of the population in developed countries have used some form of alternative or complementary medicine, including dental products. Herbal treatments are the most popular form of traditional medicine and they are highly lucrative in the international marketplace.,
Available scientific literature shows that herbal toothpastes are as effective as conventional toothpastes., The current clinical study compared the effects of two herbal toothpastes for dental caries, toothache, and oral hygiene.
DRT and DBT are two well-known polyherbal formulations. DRT comprises ingredients such as Maricha, Pippali, Shunti, Tomar beej, Lavang oil (Oil of Syzygium aromaticum), Karpoor, Pudina Satva (Mentha piperita), and Gairic Powder, which are traditionally known to be antimicrobial, pain relieving, breath fresheners, and anti-inflammatory agents that help reduce swelling in the gums. In earlier studies, the beneficial effects of DRT had been established in dental plaque, gingivitis, stain removal, and malodor.
DBT comprises ingredients such as Babool (Acacia arabica) and Clove oil, which are traditionally known for their antibacterial and antiplaque properties and help reduce gingival inflammation, fight toothache and caries. The properties of herbs contained in these toothpastes could be attributed to their therapeutic effects.
| Conclusion|| |
From the current study, it can be concluded that regular usage of all the tested toothpastes improved overall oral health, which was evident from a reduction in gum bleeding, halitosis (bad breath), microbial growth, and improvement in oral hygiene. No deterioration in the condition of caries was observed during the study period. A significant reduction in tooth pain, stain intensity, and stain area was also observed. The products also helped to maintain the salivary pH. All the tested products were assessed to be overall well tolerated and safe.
Financial support and sponsorship
The study was sponsored by Dabur India Limited, Ghaziabad, India.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3], [Table 4]