Clinical Evaluation Of Homeopathic Mouthwash Compared With Chlorhexidine (0.2%): A Randomized Controlled Study

Keywords

Chlorhexidine; Homeopathic Mouthwash; Gingivitis.

Introduction

Oral cavity is reflected as a mirror of general health.Througho- Inflammatory damage of gingiva and periodontal ligament can occur due to chronic inflammatory diseases of the periodontium resulting into Periodontal disease.[1] These diseases affect tissues, bone and teeth supporting structures. They are caused by local etiologic factors like microbial plaque accumulating at or near the tooth surface.[2] Bacterial plaques are the primary etiological cause of chronic gingivitis.[1]

Significant quantity of bacterial plaque comprisingof virulent pathogens collects over teeth due to improper oral hygiene practices in many individuals. Hence efficient oral care is important for all individuals.[3]

With the advancement in the field of dentistry, various preventive and prophylactic measures are emerging day by day, targeting the causative factors of the oral diseases.[4] Chemotherapeutic and antimicrobial agents play a significant role, as the preventive agents in such treatment modalities.[5] Chlorhexidine (CHX) a chemical agent has the ability to inhibit plaque formation to a larger extent. It is used in the form of mouthwash, gel, sprays, varnishes, toothpastes and also in irrigators.[6] It is definitely used widely as the most common choice of mouthwash but not ignoring its side effects like taste alterations or mucosal irritation etc. limits its use in Pediatric field.[7-9] Hence, finding options becomes necessary for alternative herbal or homeopathic medicine. According to the World Health Organisation, about more than 80% of the people in developing countries avail traditional medicine for primary health care. Phytotherapy involves the use of plants as medicine.[9]

Alternative medicines other than the routine ones, for treatment of dental treatments are increasing everywhere. Natural products such as Curcuma zedoaria, Azadirachtaindica, Aloe vera, Punicagranatum Linn., and other herbal products have been tested and are found to have effective medicinal properties.[10] Homeopathy is one of the alternative method, which dates back to 200 years ago. The main concept of homeopathic medications is similar to the use of vaccines, where attenuated microorganisms are used to trigger an immune response in the human body. The homeopathic philosophy considers that no one organ of the body can be ill without disturbing the person as a whole. Many homeopathic remedies help to release pain and inflammation and promote the healing of weak tissues which can be applicable to gingival and periodontal conditions too.[11]

There are insufficient studies on homeopathic mouth wash. Hence the present study was done to evaluate the efficacy of homeopathic over chlorhexidine mouth wash.

Materials and Methods

This single centered, single blind, randomized controlled trial was approved by the Institutional Ethical. This study was performed in harmony with the Helsinki Declaration of 1975, and 2013 revised edition.[12] Written informed consent was obtained from all the participants involved in this study by the treating periodontist. The study was conducted from February 2018 to October 2018. Participants aged between 20-21 years, diagnosed with gingivitis with probing depth (PD) =3 mm were included in the study. Subjects having periodontitis, any antimicrobial drug intake history in the last 6 months, any systemic illness, tobacco chewing or smoking habits, allergy to herbal medication history were excluded from the study.

Randomization

Sample was randomized using the computerized random number generator, Prism 4.0 software package was used (GraphPad, La Jolla, CA, USA). Allocation ratio was 1:1. The 40 dental students aged (20-21yrs) were randomly allocated into two groups of 20 samples in each group; Group A as test group homeopathic mouthwashand Group B as control group with chlorhexidine mouth wash.

Blinding

This single blind single center randomized controlled trial was conducted where participants were not aware about the content of mouth rinse. The mouthwashes were dispensed in amber color-coded bottles by a Homoeopathic practitioner not involved in any dental treatment, assessment or interaction with the patients. The patients were suggested to open bottles after leaving the clinic.

Intervention

The participants were randomly allocated into two groups of 20 samples in each group. Each participant was advised to rinse with the allotted mouthwash twice daily for 1 min, in the morning and at night time for 7 days.For half an hour post rinsing participants were instructed not to brush, drink or eat anything.

Thorough scaling was done to bring all students to baseline before start of study. Then they were administered with Group A (20) - 10ml of Homeopathic Test Mouthwash and B (20) - with Chlorhexidine (0.2%) Mouthwash. Samples were evaluated at baseline and also after seven days for Gingival index (GI), Periodontal index (PI)[13] and sulcus Bleeding Status (SBI). The Plaque index given by Sillness and Loe and gingival index given by Loe.Gingival Index was used to evaluate the severity of gingivitis, sulcus Bleeding Status (SBI) was usedto assess the bleeding chances in gingivitis patients. For all the clinical measurements, Williams O probe was used.

The experimental 25 ml of homeopathic mouthwash was prepared by mixing 5 ml of each Calendula, Echinacea, Heparsulpha, Plantago major and Symphytum constituents.

The primary outcomes were plaque index score and sulcus Bleeding Status, and the secondary outcomes were Gingival index score. Research hypothesis was set as“there lies a significant reduction in the clinical parameters PI, GI, SBI.

Null hypothesis was set with “there is no significant reduction in clinical parameters PI, GI, SBI for test and control groups. The obtained data was tabulated ad statistically evaluated using SPSS statistical software version 22 with Intragroup comparison of both plaque and gingival indices were done using paired t-test, whereas intergroup assessment of these indices were done with Tukey’s HSD test.P value was set below 0.5.

Results

Graph 1indicates Plaque score between Homeopathic and Chlorhexidine groups. At baseline and after 7 days after mouth rinse, there was no statistically significant difference plaque index score. There was decrease in PI from baseline to 7th day.

Graph 2 indicates Gingival score between Homeopathic and Chlorhexidine groups. There was decrease in GI from baseline to 7th day. There was statistically significant difference in GI score between homeopathic and chlorhexidine mouth wash at bassline, but at 7th day comparably decrease in GI score with homeopathic mouth rinse but it was not statistically significant.

Graph 3 indicates sulcus Bleeding Status (SBI) score between Homeopathic and Chlorhexidine groups. There was decrease in SBI score from baseline to 7th day. There was statistically significant difference in SBI score between homeopathic and chlorhexidine mouth wash at bassline, and at 7th day.

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Figure 1:

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Graph 1. Plaque score between Homeopathic and Chlorhexidine groups.

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Figure 2:

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Graph 2. Gingival score between Homeopathic and Chlorhexidine groups.

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Figure 3:

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Graph 3. Bleeding index score between Homeopathic and Chlorhexidine groups.

Discussion

The most common treatment for periodontal disease is scaling and root planning which has been confirmed as a gold standard treatment of periodontitis.[14] Mechanical and chemical methods of plaque control are required regularly during dental visits to reduce gingival inflammation and maintain periodontal health. Antiplaque, antimicrobial and antigingivitis, agents have shown to alter the dental plaquequality and quantity.As said by the WHO, Homoeopathy is the second most helpful health-care system in the world having possibility to heal diseases with negligible side effects. New treatment methods that can alter the host response towards microbial challenge.[9]

In 1800, Samuel Christian Friedrich Hahnemann, a German physicianformulated the theory of homeopathy. Homeopathy works on following principles; The law of similar: (Similiasimilibuscurantur), The law of single Remedy, The law of Minimum Dose, and Concept of vital force.[15, 16] Conventional therapy believes that symptoms of an illness are a direct result of that illness and tries to suppress them with the medicine whereas homeopathy sees symptoms as the body’s effort to overcome the sickness and pursues to support this process with the therapy, and not to defeat it.Homeopathic prescriptions are of two types mainly;i) Pathological homeopathic prescribing is a treatment specifically for the disease or ailment; and ii) Constitutional homeopathic prescribing involves analyzing a person's body type, temperament, disposition, and behavioral tendencies.[17]

Homeopathic remedies are established on a universalmethodology to health that addresses illness by stimulating the body’s own healing powers. The compound selection is based on the symptoms of patient. A homeopath chooses a compound that would trigger similar symptoms if a person took it in large amounts. In an extremely diluted form, the homeopathic remedy is thought to relieve those same symptoms. Homeopathic medicines not only eliminate the complaints of periodontal diseases but also stop progress of disease.[11] The homeopathic approach is to respect the body's attempts to heal itself and gently support. For bleeding gums with substantial loss of periodontal bone, Phosphorus 15C once daily is advised to reduce bleeding gums.[16-18]

It has been found that Calendula officinalis has antihypersentivity, anti-inflammatory, Antiprotozoal, Antispasmodic and antimicrobial activity. Hence Mouth rinsing with calendula will allow its anti-inflammatory properties to work against the swollen, irritated gums and its antibacterial properties deal with the periodontopathic microorganisms. [14]

Yadav et al evaluated the antimicrobial efficacy of Calendula Oil, extracted from the flowers of Calendula of marigold family. They evaluated the antimicrobial efficacy against Porphyromonasgingivalis, Tanerella forsythia,Fusobacteriumnucleatum,Aggregatibact eractinomycetemcomitans by minimum inhibitory concentration by tube dilution method. Authors concluded that calendula possess antibacterial activity against periodontal pathogens.[14] It has been stated that regular use of a Calendula mouthwash helps to keep gums healthy.[17]

Chopra and Chopra evaluated the efficacy of homeopathic medicine in periodontists on 53 patients. They found that homeopathicnot much effective in periodontal condition.[11] Mehta et al evaluated the homeopathic mouth wash (Freshol) over chlorhexidine as a mouth wash on plaque status, gingival status, and salivary Streptococcus mutans count on 8-14 yers old children for 14 days. They observed that Fresholwasmore efficient than chlorhexidine in decreasing the salivary mutans streptococci count.[13]

Nisha et al assessed the effictiveness of Hyper. Q in decresing dental plaque and gingival inflammation. They observed that, there was significant reduction of Plaque index (PI), gingival index (GI), sulcus bleeding index (SBI) and oral hygiene index simplified (OHIS) after sixth months of follow up with homeopathic mouth rinse as compared to saline. However, CHX was found better than Hyper.[9]

Mathie and Farrer studied the consequences of Homoeopathic prescriptions in dental practice, and they determined in their pilot study that Homoeopathic medications had higher positive outcomes in the treatment of periodontal infections, pericoronitis, abscess and toothache.[19]

Southern et al assessed the efficacy of 0.12% Chlorhexidine, placebo and Herbal Oral rinse on Dental Plaque-Induced Gingivitis using Gingival Index (GI), Plaque Index (PI), and bleeding on probing (BOP). They observed that there was no statistically significant difference with placebo at any time period.[3] Khairnar et al evaluated the anti-plaque and anti-g

ingivitis efficacy of Calendula officinalis on 200 patients. GI, PIsulcus bleeding index and OHI-S were noted at baseline to 6th month.They have concluded that calendula mouthwash is effective in reducing dental plaque and gingivitis adjunctive to scaling.[10] The present study indicated that tested homeopathic mouthwash has promising role in improving the oral health by reducing the plaque, gingivitis and sulcular bleeding.

Limitations of the present study are the smaller sample size and shorter duration of the study. Further studies are needed to evaluate with larger sample size for longer duration. A long duration of study could help in assessing the advantages and disadvantages of homeopathic mouth wash.

Conclusion

Administration of homeopathic drugs shown as effective and safe alternative to conventional modes of treatment.