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Journal of Drug Delivery and Therapeutics

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Open Access   Full Text Article                                                                                                                                                                      Research Article 

Reformulation and Scientific Evaluation of CUSOCO: A Traditional Toothpaste Formula from Classical Tamil Literature towards treatment of Halitosis

Chandran M.1, Priyanka R.1, Kavipriya D.2, Ramya S.3, Jayakumararaj R.4*, Loganathan T.5, Pandiarajan G.6, Kaliraj P.7, Grace Lydial Pushpalatha G8, Abraham GC.9 Ram Chand Dhakar10 

Department of Zoology, Thiruvalluvar University, Serkadu, Vellore-632115, INDIA

Department of Zoology, Arignar Anna Government Arts College for Women, Walajapet, TN, INDIA

PG Department of Zoology, Yadava College (Men), Thiruppalai - 625014, Madurai, TN, India

Department of Botany, Government Arts College, Melur – 625106, Madurai District, TN, India

Department of Plant Biology & Plant Biotechnology, LN Government College (A), Ponneri, TN, India

Department of Botany, Sri S Ramasamy Naidu Memorial College (A), Sattur - 626203 TN, India

Department of Zoology, Sri S Ramasamy Naidu Memorial College (A), Sattur - 626203 TN, India

PG Department of Botany, Sri Meenakshi Government Arts College, Madurai – 625002, TNIndia

PG & Research Department of Botany, The American College, Madurai – 625002, TamilNadu, India

10 Hospital Pharmacy, SRG Hospital & Medical College Jhalawar-326001, Rajasthan, India

Article Info:

_______________________________________________

Article History:

Received 22 July 2022      

Reviewed 29 August 2022

Accepted 06 Sep 2022  

Published 15 Sep 2022  

_______________________________________________

Cite this article as: 

Chandran M, Priyanka R, Kavipriya D, Ramya S, Jayakumararaj R, Loganathan T, Pandiarajan G, Kaliraj P, Grace Lydial Pushpalatha G, Abraham GC, Dhakar RC, Reformulation and Scientific Evaluation of CUSOCO: A Traditional Toothpaste Formula from Classical Tamil Literature towards treatment of Halitosis, Journal of Drug Delivery and Therapeutics. 2022; 12(5):127-131

DOI: http://dx.doi.org/10.22270/jddt.v12i5.5604          _______________________________________________

*Address for Correspondence:  

Jayakumararaj R., Department of Botany, Government Arts College, Melur – 625106, Madurai District, TN, India

Abstract

___________________________________________________________________________________________________________________

In order to achieve the multi-claim products required for dental-health-care and hygiene, it is indispensable for the formulator to use a wide range of ingredients however, with the advent of technology the chemically synthesised products are not of demand in the market as they have side effects and are considered to unsafe for human use. This places quite a number of demands on the use of PBNPs in the development process. Use of PBNPs innovations in the areas of pharmaceutical technology have contributed significantly to the formulation of dental-health-care products with superior efficacy as well as other attributes that may contribute to clinical response and patient acceptability. Improved clinical efficacy and tolerability, along with conditioning signals, should encourage patient compliance with oral hygiene. Cuminum cyminum seeds are being habitually used in traditional cuisines of different cultures. In India, it is used in both whole and ground form as a traditional ingredient to make dishes without perceptive medicinal knowledge/ properties behind. In Kerala, decoction of cumin seeds is used for drinking (Jeera water). In Tamilnadu, cumin seeds are the key ingredient of Rasam. Fruit of Solanum lycopersicum is one of the important savoury vegetable used in traditional Indian cuisines. The oil of Cocos nucifera fruits are used in cooking in Kerala and TamilNadu. In the present study, composition (paste) prepared by mixing of 2 drops of S. lycopersicum fruit juice, 2 drops of C. nucifera and 1g of C. cyminum seed powder were tested on 100 subjects with felt bad breath. Results of the present study was found to be effective in controlling bad breath (odour) in 74 subjects after the treatment (period of clinical trial) except 09 of 83 subjects who were diabetic.

Keywords: Oral hygiene; bad breath; halitosis; Cuminum cyminum; Solanum lycopersicum; Cocos nucifera; CUSOCO; dental-health-care

 


 

INTRODUCTION

Over the years, advances in oral care have significantly improved the oral health of millions of people across the world. However, incidences of dental caries and oral diseases remain on the rise due to the increase in availability of sugars in the food and increase in the consumption of soft drinks1. The change in our diets has led to an increase in dental erosion that allows oral microbial flora to flourish2. Halitosis is an unpleasant or cantankerous odour of unhygienic oral health condition and it is common among majority of human population across all age groups3. It has been pointed out that, throughout the world, nearly 30 - 50% of the population has experience the problem of halitosis4-6. Halitosis, oral malodour, or bad mouth breath is a universal medico social problem across all communities and refers to the unpleasant odour that originates from the mouth or elsewhere in the oral cavity7. Almost all the people have unpleasant oral odour at some time8. When halitosis is severe or longstanding; it may psychologically decrease the self-confidence and social interactions of affected person7. Reports have suggested that gastrointestinal diseases may cause halitosis. H. pylori infection, which causes gastric ulcers, is considered as a possible cause for halitosis9. Halitosis may be due lack of proper oral cleansing and xerostomia (dryness of mouth) oral cavity contains volatile sulphur compounds (VSCs) such as hydrogen sulphide, methyl mercaptan, dimethyl-sulphide, and organic acids10-13, and volatile sulphur compound producing bacteria associated with gingivitis and periodontitis such as Porphyromonas gingivalis, Prevotella intermedias, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Fusobacterium nucleatum, Pepto streptococcus micros, Bacteroides forsythus, Eubacterium species14 and spirochetes15, medical problems such as renal failure, cirrhosis of liver, and diabetes mellitus16-18, or it could be due to microbial degradation of proteins19, or presence of decay or retention of food between the teeth. Till date no tooth paste or oral mouth wash has been so effective in solving the long term oral problems associated with halitosis.

In the traditional Tamil Literature text Jeeragam means curing from within. Jeera - Cumin (Cuminum cyminum L.) is an annual and herbaceous plant (Family: Apiaceae). It is a multipurpose plant species cultivated in the Middle East, India, China, and several Mediterranean countries, including Tunisia. Its fruit, known as cumin seed, is most widely used for culinary and medicinal purposes20. It is generally used as a food additive, popular spice, and flavouring agent in many cuisines. Cumin has also been widely used in traditional medicine to treat a variety of diseases21-27. Pharmacological studies have proven that C. cyminum exerts antimicrobial, insecticidal, anti-inflammatory, analgesic, antioxidant, anticancer, antidiabetic, antiplatelet aggregation, hypotensive, bronchodilatory, immunological, contraceptive, anti-amyloidogenic, anti-osteoporotic, aldose reductase, α-glucosidase and tyrosinase inhibitory effects28,29. The medicinal parts were Cumin oil extracted from the ripe fruit and the ripe, dried fruit25. Phytochemical analysis of C. cyminum revealed that it contains alkaloid, coumarin, anthraquinone, flavonoid, glycoside, protein, resin, saponin, tannin and steroid28,29Hence, in the present investigation “CUSOCO” was prepared in the form of paste from cumin (Cuminum cyminum) seeds as base (primary source), fruits of tomato (Solanum lycopersicum) and oil of coconut (Cocos nucifera) as supplementary products. The formulation was clinically tested among the peoples who had halitosis condition to validate this formulation. 

MATERIALS AND METHOD

Study sample selection

In the present study, samples 100 people with in the age group of 18 and 45 y were randomly selected as a study subjects from Katpadi Town, Vellore District, TN, India. A simple questionnaire was given to each subject to record the data about the oral hygiene and halitosis. Based on the answers, 100 subjects who strongly believe existence of halitosis were randomly selected for halitosis detection test to ensure halitosis condition. Halitosis detection test was conducted in all study subjects by using organoleptic method.  Among the study subjects, 22 were females and 78 were males. 

Halitosis detection

The organoleptic method a simple, easy and frequently used method to detect halitosis30. In this method, a simple plastic tube is placed in the mouth of the person being examined, to prevent the dilution of the breath by the surrounding air and other end of the tube is very near to the nose of the assessor. While the study subjects slowly exhales, the “judges” assesses the odour at the other end of the tube. In this test the embarrassing situation between both study subjects and the assessor were avoided by keeping an opaque privacy screen between them to ensure no visual contact. All the study subjects were tested for the halitosis by this organoleptic method. The individuals with halitosis were identified and experimented with the trial formulation to validate their potentiality in prevention of halitosis and maintenance of oral hygiene. 

Experiment with halitosis affected human

The persons with halitosis were subjected to validation experiment with the trial formulation. For all patients, the paste containing herbal formulation and the procedure to prepare the tooth paste were clearly explained (1gm Cuminum cyminum + 2 drops of Solanum lycopersicum fruit extract + 2 drops of pure Cocos nucifera oil) and it was recommended that they may use this formulation instead of chemical paste already in the usage for everyday practice. The paste obtained by mixing of three food ingredients are named as CUSOCO for our convenience based on the joining of first two letters of all three food ingredients. All the patients were assessed for their halitosis level in the 0 day (just before the first day of brushing) 5th day, 10th day, 15 and 30th day after the experiment (used after the herbal CUSOCO paste). The halitosis level of all patients of from 0 to 30th days results were compared to know if any improvement exists in halitosis reduction. All the patients are requested to brush their teeth at least twice a day to achieve a healing effect and use the dental floss after eating because normal brushing cannot eliminate bacterial plaque in between teeth. In addition the study subjects were asked to practice tongue cleaning because many people have a habit of brushing their teeth but they do not know that the tongue is also a part of the practice. 

RESULTS AND DISCUSSION

The most effective way of preventing the development of dental disease is in controlling the production of dental plaque. Plaque is a soft thin layer which deposits on teeth gums and all appliances fitted in the mouth. It is formed by microbial action31. Halitosis is a common no-risk health problem among humans and can be caused by oral or non-oral factors. The term Halitosis32 derived from halitus (breathed air) and the osis (pathologic alteration). It means disagreeable bad or unpleasant odour emanating from mouth-breath. More than 50% of general population have halitosis33. Most of the bad breath comes mainly due to inadequate hygiene or due to hygiene deficient in contact points, the formation of periodontal pockets due to the presence of supra-gingival or sub-gingival plaque or calculus and the surface of the tongue, whose anatomy favours the accumulation of bacteria34-37. Such a condition has no health-risk. However, social anxiety among halitosis patients is high; it tends to precede depression and alcoholic dependence. Worldwide, one-third of social anxiety disorder patients have concomitant psychological disorders such as depression or alcohol dependence. Mood disorders, particularly major depression, was the most common other lifetime diagnosis (70.2%). A large majority (70.2%) suffered from, at least, one other anxiety disorder in their lifetime and, in particular, panic disorder with or without agoraphobia (49.1%). Alcohol (28.1%) and substance (15.8%) abuse or dependence were also common lifetime diagnoses38. Sometimes, social anxiety disorder amalgamated with other psychological diseases leads to increase the risk of suicide39. Excessive anxiety in social situations causes a considerable distress and impairs in functional ability in daily lives40. Most of the halitosis patients turn to “soft” medicine that offers a wide range of disciplines to treat bad breath; homeopathy, herbal medicine and aromatherapy as an alternative treatments, or complementary to conventional medicine. In India, particularly in Tamilnadu, majority of the people used the traditional mode of treatment to treat the halitosis41. Hence, in the present investigation, the herbal treatments which were used generation by generation to treat halitosis were experimented on halitosis affected persons to validate and evaluate their potential in curing halitosis. 

For this study, totally 100 individuals who felt the bad mouth smell was randomly selected and they were re-checked and confirmed by organoleptic method. According to the obtained results of the present study, five individual out of 100 has pseudo-halitosis effect. Even though, these five individuals are not having any bad smell in their mouth they are psychologically worried about the halitosis. Sometimes people who do not have symptoms of halitosis yet feel like having it are referred to as pseudo-halitosis or halitophobia42. Five (5) individuals with pseudo halitosis, identified using organoleptic test were counselled on 1st day and were excluded from the study. Likewise, 12 individuals self-reported for halitosis but not having halitosis were identified and excluded from the study. The final set comprising of 83 study subjects excluding 12+5 individuals were tested with the CUSOCO formulation. 

Results of the organoleptic test showed 30 individuals with discontinuous halitosis, 29 individuals with slight halitosis and remaining 24 individuals with worst halitosis condition. The herbal formulation CUSOCO was recommended to all (88) subjects out of 100 except the sampling individuals (12) who are not having any halitosis. The halitosis conditions of all 88 individuals were checked by organoleptic method 0, 7, 15 and 30th days after the use of this herbal tooth paste to brush the tooth. The obtained results showed 67 individuals are not having any bad smell in their mouth have some concordance with the findings that in-vivo study of chlor-hexidine mouth rinse, containing pericarp extracts of Garcinia mangostana L. showed a significant reduction of VSCs level in gingivitis patients43.

However, 14 individuals had a moderate level of smell and remaining 7 are not having any improvement out of 88 individuals (Table 1). The results of 15th day observation showed 75 individuals without any halitosis, 6 individuals with moderate halitosis and 7 individuals without any improvement. On the 30th observation exhibited 81 individuals are not having any halitosis showed a similarity with that report of toothpaste mixed with Chinese herb extract showed better in vitro inhibition effect on VSCs genesis anaerobic bacteria than most other toothpaste on market. Even after 30 days treatment, 7 individuals are not having any improvement in their halitosis condition were reanalysed to find weather it may be due to oral and dental problems or some other problems. 

The results of the present study observed at 0 days and 7th day, 15th day and 30 day of experiment interprets that both worst halitosis (24) and moderate halitosis (59) of 0 days drastically reduced to 07 and 14 at 7th day observation. The halitosis reduction in worst and moderate patients gives clear cut evidence for the ability of present herbal composition in curing halitosis. The worst halitosis observed at 7th day was not observed further change upto 30th day. But moderate conditions of 14 individuals were further reduced the numbers to 06 and level to 0 at 15th and 30th day observation Table 2, Fig. 1. 

Many plants such as Elettaria cardamomum, Salvadora persica, Illicium verum, and Origanum vulgare were widely used by 76% traditional healers to treat halitosis and 64.9% patients themselves used to treat halitosis without any scientific validation. Salvadora persica, (Miswak) was widely used to treat halitosis because of anti-inflammatory effect44 and contains vitamin C that helps in healing gingival edema and bleeding45. The alcoholic extract of Curcuma zedoaria was used auxiliary component in the mouthwash to treat dental plaque and gingivitis46Hence, in the present investigation, the traditional preparation CUSOCO was evaluated for its efficacy on the management of halitosis.

 

CONCLUSION

In the present study, composition (paste) prepared by mixing of 2 drops of S. lycopersicum fruit juice, 2 drops of C. nucifera and 1g of C. cyminum seed powder were tested on 100 subjects with felt bad breath. Results of the present study was found to be effective in controlling bad breath (odour) in 74 subjects after the treatment (period of clinical trial) except 09 of 83 subjects who were diabetic. However, phytocompounds present in CUSOCO formulation must be scientifically analysed and validated before put to regular practice.

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Table 1 Validation of herbal composition CUSOCO on halitosis patients 

Halitosis condition

Number of Individuals

0 day

7th day

15th day

30th day

Worst

24

07

07

07

Moderate

59

14

06

0

Pseudo halitosis

0

0

0

0

Without halitosis

0

67

75

81

Total

83

84

88

88

 

Table 2 Statistical analysis to validate herbal composition CUSOCO 


0_day

7th_day

15th_day

30th_day

N

5

5

5

5

Min

0

0

0

0

Max

83

84

88

88

Sum

166

172

176

176

Mean

33.2

34.4

35.2

35.2

Std. error

16.48454

17.13651

19.05098

20.19752

Variance

1358.7

1468.3

1814.7

2039.7

Stand. dev

36.86055

38.3184

42.5993

45.16304

Median

24

14

7

7

25 prcntil

0

3.5

3

0

75 prcntil

71

75.5

81.5

84.5

Skewness

0.555019

0.64357

0.643047

0.604361

Kurtosis

-1.88517

-2.59681

-2.99874

-3.2303

Geom. mean

0

0

0

0

Coeff. var

111.0257

111.3907

121.0207

128.3041

 


Table 2 Box plot analysis of data on validation of herbal formulation