|Year : 2015 | Volume
| Issue : 3 | Page : 218-221
Effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis: A randomized controlled trial
Roopali Gupta1, Navin Anand Ingle1, Navpreet Kaur1, Pramod Yadav1, Ekta Ingle2, Zohara Charania3
1 Department of Public Health Dentistry, K. D. Dental College and Hospital, Mathura, Uttar Pradesh, India
2 Department of Oral Medicine and Radiology, Vasantdada Patil Dental College, Sangli, Maharashtra, India
3 Department of Public Health Dentistry, Guardian Dental College, Amarnath, Mumbai, Maharashtra, India
|Date of Web Publication||14-Sep-2015|
Department of Public Health Dentistry, K. D. Dental College and Hospital, Mathura, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Introduction: Dental plaque is a well-known etiologic factor for gingivitis. Ayurvedic drugs have been used since ancient times to treat diseases including periodontal diseases. Toothpastes made from herbal medicines are used in periodontal therapy to control bleeding and reduce inflammation. Aim: To compare the effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis among residents of ladies hostel in Mathura City. Materials and Methods: A randomized controlled clinical trial was carried out on 60 participants aged 18-30 years residing in a ladies hostel of Mathura City. The 60 participants were randomly allocated into two groups: Group-I: Experimental group using herbal toothpaste, Group-II: Control group using fluoridated toothpaste. The subjects were asked to brush twice daily with the assigned dentifrice using standardized brushing technique for 46 days. The plaque and gingival indices were recorded according to Silness and Loe (1964) and Loe and Silness (1963), respectively. These parameters were assessed at baseline, 3 weeks, and 6 weeks. Data were analyzed by Student paired t-test and unpaired t-test using Statistical Package for the Social Sciences version 21 manufactured by IBM Corporation - Armonk, New York, US. Results: Baseline plaque and gingival scores were found 1.02 ± 0.02 and 0.88 ± 0.06 for the experimental group and 1.02 ± 0.03 and 0.81 ± 0.08 for control group, respectively. After 6 weeks plaque and gingival scores were found 0.77 ± 0.07 and 0.72 ± 0.08 for experimental group and 0.78 ± 0.07 and 0.73 ± 0.11 for control group, respectively. Statistically significant differences were obtained before and after intervention in both groups (P ≤ 0.05). Conclusion: The herbal toothpaste was as effective as the conventionally formulated fluoride dentifrice in controlling plaque and gingivitis.
Keywords: Dental plaque, dentifrice, fluoride, gingivitis, herbal toothpaste
|How to cite this article:|
Gupta R, Ingle NA, Kaur N, Yadav P, Ingle E, Charania Z. Effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis: A randomized controlled trial. J Indian Assoc Public Health Dent 2015;13:218-21
|How to cite this URL:|
Gupta R, Ingle NA, Kaur N, Yadav P, Ingle E, Charania Z. Effectiveness of herbal and nonherbal fluoridated toothpaste on plaque and gingivitis: A randomized controlled trial. J Indian Assoc Public Health Dent [serial online] 2015 [cited 2019 Nov 13];13:218-21. Available from: http://www.jiaphd.org/text.asp?2015/13/3/218/165207
| Introduction|| |
Dental caries and periodontal diseases, the two arch criminals of the oral cavity, are essentially caused by the microorganisms present in the dental plaque.  The use of toothpaste has ancient roots. Ancient Greeks, Egyptians, and Roman civilization were known to develop their own tooth "powder" containing pumice, talcum, coral powder.  W.D. Miller ushered a new era in the science of preventive dentistry in 1890 when he described his chemicoparasitic theory of tooth decay. This new theory created a boom in the toothpaste industries, with each manufacturer adding special agent/agents. The more modern aspect of dentifrice came after the second world war and with greater understanding about the pathogenesis of periodontal disease. 
Dental plaque is mainly composed of bacterial aggregations and pellicle. It is well-known that the microorganisms in plaque produce numerous enzymes, toxins, and lipopolysaccharides. These are known to cause substantial changes in the periodontal tissues.  There is ample evidence to implicate dental plaque as the primary etiological agent responsible for periodontal disease and caries.  Various studies conducted throughout the world have proven that the incidence and prevalence of periodontal disease are high and dental plaque is virtually associated to it.  Clinical studies related to the removal of plaque and remission of gingivitis had been accepted as support for a definite relationship between plaque and gingivitis and for the belief that a significant factor in the maintenance of gingival health. 
More recently it has been found that the chemical antimicrobials and metal ions have their own gross limitations. Thus, it may be seen that the alternative approach are undoubtedly very much essential for the control and understanding the nature of inhibition of the plaque.  The studies conducted for evaluating the efficacy of the herbal dentifrices in plaque control and gingivitis prevention, and their comparison with other conventional dentifrices are few in number. Hence, the aim of this study was to compare the efficacy of an herbal dentifrice with a fluoridated dentifrice in plaque control and gingivitis prevention.
- To record plaque and gingivitis scores of the study participant at baseline, 3 weeks, and 6 weeks among 18-30-year-old women in ladies hostel in Mathura City
- To compare the efficacy of herbal and fluoridated toothpastes in controlling plaque and gingivitis.
| Materials and methods|| |
A double-blind, randomized controlled clinical trial was carried out on 60 participants aged 18-30 years residing in a ladies hostel of Mathura city. The pilot study was conducted among 10 participants to test the applicability and feasibility of the protocol. Based on the results of the pilot study, some minor modifications were made in the protocol and used in the main study. Ethical approval was taken from the Institutional Review Board and also necessary permissions were taken from the head of the institution. Informed consent was obtained from all the study participants. The participants and the outcome assessor were blinded as to the actual toothpaste received by the participants.
The inclusion criteria includes willing participants with good general health, a regular user of toothbrush and toothpaste, baseline plaque score should be >1-1.9. The exclusion criteria includes participants undergone any recent antibiotic therapy, history of early onset periodontitis, acute necrotizing ulcerative gingivitis, gross oral pathology, treatment for cancer, participants who wore orthodontic appliances, fixed or removable prosthetic appliances.
A total of 85 hostlers were present at the time of study but based on inclusion and exclusion criteria only 60 participants were eligible to participate and then they were randomly allocated into two different groups that is, control group (fluoridated dentifrice [n = 30]) and experimental group (herbal dentifrice [n = 30]) by a toss of a coin method. The random allocation sequence was generated and concealed from the main investigator. The investigator and the study participants were unaware of allocated groups of both toothpaste.
Participants in control group received a Close-up Anticavity toothpaste in which each tube contains 100 g (water, sorbitol, calcium carbonate, hydrated silica, sodium lauryl sulfate, trisodium phosphate, benzyl alcohol, sodium monofluorophosphate, cellulose gum, PEG-32) and participants in experimental group received a Himalaya Dental Cream and each tube contains 100 g (Punica granatum - 2.57 mg, Zanthoxylum alatum - 1-0.8 mg, Acacia Arabica - 1.71 mg, Embelia ribes - 1.71 mg, Vitex negundo - 1.14 mg, Vaikranta bhasma - 2 mg, Azadirachta indica - 1.44 mg, Carum Copticum - 1 mg, Pilu, Irimeda, Saccharine sodium).
Study was conducted between 4 pm and 6 pm in girls' hostel. The questionnaire consisted of Part I about the participant's demographic profile. Part II comprised questions assessing participant's oral hygiene practices. Part III aimed at evaluating the food habits and sweets intake of the participants. Part IV included clinical examination for assessing plaque and gingivitis by using indices according to Silness and Löe (1964)  and Loe and Silness (1963), respectively. These parameters were assessed at baseline, 3 weeks, and 6 weeks.
The subjects were asked to brush twice daily with the assigned dentifrice using a standardized brushing technique with a soft bristled adult toothbrush for 46 days. The dentifrices were distributed to the subjects. They were also told to refrain from other toothpastes except the directed ones. They were also given an additional toothpaste if in case their first toothpaste get over. At the end of the study, all the subjects were given a thorough, and complete oral prophylaxis including the removal of supragingival and subgingival plaque and calculus deposits and then the teeth were polished. The subjects were educated to use the same toothpaste and technique for brushing provided to them for 46 days. They were educated and reinforced regarding this on a regular basis by the examiner who visited to the hostel every 3 rd day for the education purpose and to confirm whether instructions were followed.
The data obtained from the study were compiled, tabulated, and subjected to statistical analysis. Data obtained were analyzed using Statistical Package for the Social Sciences version 21 manufactured by IBM Corporation -Armonk, New York, US. Student paired t-test and unpaired t-test was applied to assess between-group differences. A P ≤ 0.05 had been considered as statistically significant.
| Results|| |
A total of 60 participants were taken 30 in each group on whom the final statistical analysis was done. Age range for the control group and experimental group were 22.8 and 22.6, respectively. Frequency of brushing: Once daily in the experimental group was 18 (60%) and control group it was 15 (50%). Frequency of brushing: Twice daily in the experimental group was 7 (23.3%) and in the control group it was 8 (26.7%). Use of oral hygiene aids was 12 (40%) in the experimental group and 17 (56.7%) in the control group. Frequency of changing of the toothbrush was 4-6 months in experimental group 11 (36.7%) and in the control group it was 10 (33.3%). Use of mouth rinse after eating in the experimental group was 8 (26.7%) and in the control group it was 5 (16.8%) [Table 1].
|Table 1: Distribution of participants according to their oral hygiene practices |
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Mean plaque scores for the control group were 1.02 ± 0.03, 0.8 ± 0.09, and 0.7 ± 0.07 at baseline, 3 weeks, and 6 weeks, respectively. Mean gingival scores for the control group were 0.8 ± 0.08, 0.7 ± 0.11, and 0.7 ± 0.11 at baseline, 3 weeks, and 6 weeks, respectively. Mean plaque scores for the experimental group were 1.02 ± 0.02, 0.8 ± 0.09, and 0.7 ± 0.07 at baseline, 3 weeks, and 6 weeks, respectively. Mean gingival scores for the experimental group were 0.8 ± 0.06, 0.7 ± 0.11, and 0.7 ± 0.08 at baseline, 3 weeks, and 6 weeks, respectively. An unpaired t-test was applied; there was no statistically significant difference found among the groups [Table 2].
When a paired t-test was applied within the groups, differences between mean plaque scores at baseline versus 3 weeks and baseline versus 6 weeks were found to be statistically highly significant (P ≤ 0.001) in control group and mean plaque score at baseline versus 3 weeks and baseline versus 6 weeks were found to be statistically highly significant (P ≤ 0.001) in experimental group. Gingival score in the experimental group at baseline versus 6 weeks were found to be statistically highly significant (P ≤ 0.001). Except the gingival scores at baseline versus 3 weeks and baseline versus 6 weeks in control group and gingival scores in baseline versus 3 weeks in experimental group were found to be statistically significant (P ≤ 0.05) [Figure 1].
|Figure 1: Comparison of gingival and plaque scores of groups at different intervals|
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| Discussion|| |
Maintenance of good oral hygiene is the key to prevent dental diseases. The activities of the oral microflora are the cause for most oral disease and mouth odor. The addition of antibacterial agents in the production of toothpaste aids in keeping these oral organisms to a level consistent with oral health. 
In the present study, the plaque scores at baseline for control group were 1.02 ± 0.03, 0.8 ± 0.09, and 0.7 ± 0.07 at baseline, 3 weeks, and 6 weeks, respectively, and plaque scores for the experimental group were 1.02 ± 0.02, 0.8 ± 0.09, and 0.7 ± 0.07 at baseline, 3 weeks, and 6 weeks, respectively. Gingival scores for control group were 0.8 ± 0.08, 0.7 ± 0.11, and 0.7 ± 0.11 at baseline, 3 weeks, and 6 weeks, respectively, and gingival scores for experimental group were 0.8 ± 0.06, 0.7 ± 0.11, and 0.7 ± 0.08 at baseline, 3 weeks, and 6 weeks, respectively, which is in accordance with the standard protocol to examine plaque and gingival scores. When an intergroup plaque and gingival score comparison was done, no statistically significant difference found. Similar results were obtained in studies conducted by Ozaki et al.,  Pannuti et al.,  Shama Rao et al.  In contrast to this study, significant differences in gingival and plaque indices were obtained for the experimental group and not for the control group in a study conducted by George et al. 
In this study, when intragroup comparison was done within the groups, differences between mean plaque and gingival scores at baseline, 3 weeks, and 6 weeks were found to be statistically highly significant (P ≤ 0.001) in both experimental and control groups. Similar results were obtained in the studies conducted by Ozaki et al.  and Shama Rao et al.,  George et al.  It is evident in the present study that the plaque and gingival scores at 3 and 6 weeks were reduced when compared to baseline in both groups. This could be attributed to the fact that both groups received toothpaste with active ingredients to reduce plaque and gingivitis.
As both groups received health education regarding brushing techniques and toothpastes with active ingredients, the possibility of the Hawthorne effect due to being singled out or made to feel important is very minimal if at all present it would be distributed equally in both the groups. Females are chosen as participants because being female examiner it was convenient to perform the study and follow-up, and also some hormonal influence occurs at puberty, which leads to gingivitis.
A limitation of this study is that small sample size of the study might have influenced the study results. Hence, further studies are recommended to include larger sample size with both the gender are suggested to test the herbal based product as an efficacious alternative to conventional dentifrice formulations.
| Conclusion|| |
Herbal dentifrice showed no significant clinical advantage over the conventional toothpaste with fluoride. However, there was a reduction in the plaque and gingivitis index scores when a comparison was done from the baseline to 3 weeks and from 3 weeks to 6 weeks in both control and test groups.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]