6.1 Need for the study:
Dental caries and gingivitis are both associated with the accumulation of bacterial plaque on and around the teeth. Therefore prevalence of these two diseases should be affected by methods aimed at preventing plaque formation or removing plaque from the teeth.1
For gingivitis, plaque represents the single most important etiological factor. But the etiology of caries appears complex and is certainly dependent on interplay of a numerous variables.1
Self-performed mechanical plaque removal is an unquestioned method of plaque control.2 Tooth brushing with a dentifrice is most widely practiced form of oral hygiene in most countries.3
Awareness of the public is increasing with regard to natural products in search for solace in traditional or indigenous medicines.4 Today, traditional medicine is becoming popular probably due to factors such as availability, affordability, cultural familiarity and family influence.5 In light of these facts, dental health care approach is directed toward holistic methods like ayurveda and homeopathy in managing diseases and conditions related to oro-facial structures.6
Ayurveda is one of the oldest systems of medicine. Ayurvedic herbs have nature’s own power of remedies. Formulated herbal tooth powder and paste are available that are effective and safe for number of diseases .These ingredients are combined in such a way that helps in cleaning of teeth, prevention from various dental problems such as bleeding gums, sensitive tooth, formation of tartar etc.6
Homeopathy can also be used alongside conventional treatments in clinical dental care. It is a safe, non-addictive and effective. Many homeopathic remedies have been found to be effective for conditions especially dental caries, dental abscess, oral lesions and post extraction bleeding, reduction of dental phobias and anxiety.6,7
With this knowledge in background the present study is planned with the aim to evaluate and compare the effects of commercially available herbal, homeopathic and conventional toothpastes on plaque accumulation and gingivitis, their effect on salivary pH and Mutans Streptococci counts in saliva.
6.2 Review of literature:
A randomized controlled clinical trial was conducted in Brazil wherein a herbal based dentifrice was used on 48 volunteers with chronic gingivitis to verify the efficacy in the reduction of plaque and gingivitis compared to dentifrice with triclosan and fluoride that served as a positive control. A significant reduction was observed in both the groups in Plaque index (Tureskey’s modification of Quigley Hein plaque index) and Gingival Index although there was no significant difference between them.2
A study was conducted in India to evaluate plaque and gingival status in 30 children aged 8-10 years by daily supervised tooth-brushing for a period of 21 days with commercially available herbal dentifrice in comparison with non-herbal dentifrice. Though herbal dentifrice showed more effectiveness than non-herbal dentifrice in reduction of gingival index scores, there was no statistical significance between the two groups.4
A randomised double-blind placebo-controlled study was conducted in Srilanka on 60 healthy dental students of ages 18-35 years to evaluate the effects of a herbal toothpaste on gingival bleeding, oral hygiene and aerobic and anaerobic microbial counts in comparison with a placebo toothpaste. At the end of 12 weeks the test group had a statistically significant improvement in mean plaque score, bleeding score and total salivary anaerobic counts compared to that of the placebo group. There was no statistically significant change in salivary aerobic counts in both the test and the placebo groups.5
A double blinded parallel control clinical trial with parallel groups was conducted in India on 30 subjects aged between 18-65 years to investigate the effectiveness of a herbal-based dentifrice in control of plaque and gingivitis in comparison with a conventionally formulated dentifrice and effect on salivary pH was also evaluated in the two groups. At the end of study there were statistically significant reductions in the gingival index and plaque index scores within the test group. However there was no statistically significant difference between the test and control groups. The salivary pH changes were not statistically significant in the test group but were displaced more towards acidic range in the control group.8
An in-vivo study was conducted in India for comparison of two commercially available toothpastes on salivary Streptococcus mutans counts in 100 urban pre-school children of age group 4-6 years for 5 months. One of them was a herbal toothpaste containing Neem with no added fluorides and the other being a fluoridated tooth paste containing 458ppm fluoride. The results obtained showed steady decrease in the bacterial count after 5 months in both the groups. But there is no statistically significant difference between the two test groups.9
An in-vivo study was conducted in Iran on 40 volunteers to investigate the efficacy of Calendula officinalis extract toothpaste with placebo toothpaste in reducing gingival inflammation and plaque formation. At the end of study after 4 weeks it was concluded that brushing with calendula toothpaste led to significant reduction in plaque index, gingival index and bleeding on probing.10
Objectives of the study
To evaluate and compare clinical effectiveness of an herbal, a homeopathic, a conventional and a placebo dentifrice on gingival index and plaque index.
To evaluate and compare effect of an herbal, a homeopathic, a conventional and a placebo dentifrice on salivary pH.
To evaluate and compare effectiveness of an herbal, a homeopathic, a conventional and a placebo dentifrice on Mutans Streptococci count in salivary samples.
MATERIAL AND METHODS
7.1 Source of data:
The present study will be conducted among subjects aged 35 – 44 years in Davangere city, Karnataka.
7.2 Method of collection of data (including sample size, inclusion criteria, exclusion criteria if any):
Randomized controlled doubled blinded clinical trial with parallel group study design.
Subjects selected as per inclusion and exclusion criteria will be randomly allocated to study groups and control group.
Sample size and design:
Pilot study was conducted to check the feasibility of the study.
Sample size is determined after the pilot study, using the formula
tα = theoretical value of t distribution with 95%confidence interval = 2.13
s = pooled standard deviation = 0.4 (based on previous studies)
d = Minimum expected difference in the reduction of colonies=60
n = Sample size
Level of Significance α =5%
Estimated Power of Study= 1-β = 100-20 = 80%
So sample size is approximately 12
Based on the above calculations, to compensate for dropouts if any, a sample size of minimum 20 subjects in each group will be used thus totalling to effective sample size of 80.
They will then be randomly divided into 4 groups with 20 participants in each group based on inclusion and exclusion criteria
The four study groups are,
Group I - Herbal based commercial dentifrice.
Group II - Homeopathic based commercial dentifrice.
Group III - A commercially available dentifrice with one of the active
ingredient as fluoride as positive control.
Group IV - A placebo dentifrice as negative control.
Procurement of the dentifrices:
The test dentifrices will be obtained from a local market in Davangere.
Preparation of placebo dentifrice:
The placebo dentifrice will be prepared using the following ingredients: sodium lauryl sulfate as detergent, hydrated silica as abrasive, carboxymethylcellulose as binder, flavoring agent, methyl-p-oxybenzoate as preservative, saccharin, sodium metaphosphate and de-ionized water with no active ingredient.
Subject with informed/written consent
Subjects having Gingival Index (GI) mean > 1.0
Presence of at least 20 natural permanent teeth.
Individuals under antimicrobial therapy at least 1 month prior to the study and using mouth rinses or dentifrices containing substances with anti-inflammatory properties.
Subjects who are medically compromised
Patient with intra oral appliance or dentures
Blinding and Masking:
Blinding and masking will be done to minimize concealment bias. Subject and examiner will be blinded (double blind). Masking will be done to ensure that all the test dentifrice tubes resemble in their physical qualities like size, shape, quantity and colour.
Method of Examination:
Purpose of the study will be explained to the study subjects and demographic details will be taken in a proforma and a thorough clinical examination will be conducted.
All the subjects will be provided with their assigned products and instructed to brush their teeth with the allocated toothpaste for two minutes both in the morning and before going to bed in the night. Subjects will be instructed to refrain from any other means of plaque control.
The subjects will be examined for plaque and gingivitis at baseline and after 15 days, 30 days, 45 days and 60 days by a single, previously calibrated examiner using Plaque index (PI) (Tureskey’s modification of Quigley Hein plaque index) and Gingival Index (GI) (Loe and Silness)
Instruments and materials:
Mouth mirror, Explorer, Tweezers, Kidney tray, Enamel bowl, Gloves, Mouth mask, Cotton, disinfectant solution, Culture media and Petri dish.
Saliva sample collection:
Before assigning respective dentifrices to groups, salivary samples will be collected at baseline in the morning before any oral hygiene practice. Un-stimulated whole saliva will be collected from each subject in a sterile container. The collected saliva will be transferred to the microbiology laboratory on the same day. Analyses of the samples will be done on the same day. Samples will again be collected at 15 days, 30days, 45days and 60 days after the use of assigned dentifrice. The saliva samples will be subjected for pH analysis and microbial analysis for quantification of Mutans Streptococci.
Saliva pH analysis:
Un-stimulated saliva collected at baseline, 15 days, 30days, 45 days and 60 days after the use of assigned dentifrice is subjected to salivary pH analysis using a pH meter.
Salivary microbial analysis:
Salivary samples collected will be subjected to serial dilution. Mutans Streptococci will be quantified in the laboratory by culturing on Mitis Salivarius Bacitracin (MSB) agar. The Colony Forming Units (CFU) of the micro organism on the culture plates will be counted using the Colony Forming Units Counter.
Results will be subjected for appropriate statistical analysis
Mean and standard deviation of the observations will be calculated.
For inter-group comparison of microbial analysis (colony counts), Kruskal-Wallis Analysis of Variance will be used followed by Mann-Whitney test for
pair wise comparison. For intra-group comparison at different time intervals, Wilcoxon-signed rank test will be used.
For comparison of Gingival Index and Modified Plaque Index scores at baseline, 15, 30, 45 and 60 days, for both inter-group and intra-group comparisons, One-way Analysis of Variance (ANOVA) followed by the Tukey’s post hoc test will be used.
p value <0.05 will be considered statistically significant.
SCHEMATIC REPRESENTATION OF STUDY DESIGN
Not meeting inclusion criteria,
Declined to participate,
Final sample n=80
Subjects assessed for eligibility
Fluoride containing conventional commercial dentifrice
Herbal based commercial dentifrice
Homeopathic based commercial dentifrice
Assessment of Gingival & Modified Plaque Index, Salivary pH, Microbial count
Assessment of Gingival & Modified Plaque Index, pH of Saliva, Microbial counts
Assessment of Gingival & Modified Plaque Index, pH of Saliva, Microbial count ccounts
Assessment of Gingival & Modified Plaque Index, pH of Saliva, Microbial count
Assessment of Gingival & Modified Plaque Index, pH of Saliva, Microbial count
Compilation of data
Analysis and Results
Duration of study: 8 months
7.3 Does the study require any investigation (or) intervention to be conducted on patients (or) other humans (or) animals? If so please describe briefly :
Baseline examinations will be done by a single examiner and scores of Gingival index and Modified Plaque index will be recorded. All the subjects will be provided with their assigned products and instructed to use them twice daily. All the subjects will be instructed to refrain from any other routine oral hygiene practices, if any. At 15 days, 30 days, 45 days and 60 days assessment will be made by the same examiner using the same indices and saliva sampling will be done followed by analysis of salivary pH and salivary Mutans Streptococci counts.
7.4 Has ethical clearance been obtained from your institution?
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Amonian B, Moghadamnia AA, Mazandari M, Amoian MM, Mehrmanesh S. The effect of Calendula extract toothpaste on the plaque index and bleeding on probing in Gingivitis. Research Journal of Medicinal Plant 2010;4(3):132-40.