ABSTRACT
Background: Varm-e-lissa is one of the most common chronic infections in the gingival crevices is induced by accumulation of dental plaque. It is one of the most frequently occurring oral diseases at any age, but most prevalent and severe in adolescence affecting more than 90% of the population. To evaluate the efficacy and safety of Unani drugs in gingivitis, a clinical study was contemplated.
Material and methods: A controlled randomized single blinded clinical study was conducted in 99 patients of mild to moderate gingivitis. Test group (n=49) was served with Unani drugs and control group (n=50) with Tripala choorna for 28 days. The pre and post study effects were assessed by gingival and plaque indices.
Results: Test group showed statistically significant reduction comparatively earlier than the control group in swelling of gums, bleeding on brushing, bacterial plaque, Gingival Index and Plaque Index.
Conclusion: This study revealed that the test drug has shown precedence over the control drug by effectively reducing the subjective and objective parameters without any adverse effects. Therefore, it is concluded that the “test drugs” can be used in the management of mild to moderate gingivitis.

Keywords: Gingivitis; Varm-e-lissa; Unani drugs; Tripala choorna.

INTRODUCTION

Varm-e-lissa is the term used for gingivitis in Unani literature and defined as an inflammatory process of the gums which is caused by poor oral hygiene and derangement in humours (ghaire tabaee akhlat). This condition is characterized by swollen, painful, reddish and bleeding gums (Anonymous, 2004). In modern medical literature, gingivitis is a term used to describe non-destructive periodontal disease. It is one of the most common chronic infections in the gingival crevices (Krasse et al., 2006) due to inflammatory process which limited to the gingiva (Salgado et al., 2006). It is induced by accumulation of dental plaque (Grau et al., 2004), characterized by gingival erythema, oedema, changes in contour, loss of soft-tissue adaptation to the teeth, bleeding (Kumar et al., 2011) on brushing, tender to touch and bad breath (Mayo Clinic, 2012).In the
absence of treatment, inflammation and degradation of collagen increases the gingivitis may develop into periodontitis (Krasse et al., 2006), which is a destructive form of periodontal disease.
The purpose of the study was to compare and evaluate the efficacy of Unani drugs in comparison to a control formulation on clinical parameters of naturally developed gingivitis and also to validate the effects of Unani drugs.

MATERIALS AND METHODS

This study was conducted at Dental Clinic, National Ayurvedic Teaching Hospital, Kotta Road, Borella, Colombo, Sri Lanka from October 2007- April 2008 after the approval of the Institutional Research Committee, Dept. of Community Medicine, University of Colombo. A total of 120 mild to moderate cases of gingivitis were screened, out of which only 99 patients randomly allocated into test (n=49) and control (n=50) groups. Inclusion criterion were patients of both gender, aged 15-55 years, with bleeding on probing / brushing, swollen gums and or bacterial plaque in the gingival margin. All subjects should have at least 24 natural teeth, among which the 4 posterior teeth in the lower left quadrant (experimental teeth) should have the disease involvement (experimental teeth). All participants were informed about the nature of the study and obtained the informed consent form in compliance with the study guidelines. Subjects with severe dental or gum infections and any other systemic illnesses were excluded from the trial.
The test group was received decoction (Joshanda) of Punica granatum (35g), Zizyphus jujuba (35g) and Rubia cordifolia (25g) (Anonymous, 2004) for gargle three times a day for 28 days with powder (Safoof) of Borax (Anonymous, 2004), Quercus infectoria and Piper cubeba to apply over the gums twice a day for 14 days, whereas, the control group was received luke warm salt water (Fischman, 1997) for gargle and ‘Tripala Choorna’ (Maurya et al., 1997) to apply over the gums for the same duration similar to that of test group.
The study effect with reference to baseline therapy was assessed based on periodontal conditions by using Modified Gingival Index (MGI) by Lobene (1986) (Butler et al., 2011 and Sharma et al., 2004) (0- absence of inflammation, 1- mild inflammation of any portion the gingival area, 2- mild inflammation of the entire gingival area, 3- moderate inflammation of the gingival area, 4- severe inflammation of the gingival area) and Plaque index (PI) by Silness & Loe 1964 (Lindhe et al., 2003) (0- no plaque, 1- a film of plaque adhering to the free gingival margin, apparent on tip of probe, 2- visible plaque , 3-abundant plaque) as objective parameters; and subjective symptoms of gingivitis like swollen gums, bad breath (halitosis), bleeding gums and bacterial plaques in four different follow ups on 7th, 14th, 21st and 28th days.
PI and GI were recorded by the qualified and trained examiner on the mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual surfaces of the experimental teeth. The gingival tissues were inspected for the presence of bleeding after running the tip of a WHO probe along the gingival margin. The values of six surfaces of each tooth were recorded to obtain the PI and GI means.

Study design
Randomized single blind control.

Statistical analyses
The Friedman test, Kruskal-Wallis test with Dunn’s Multiple Comparison test were used to evaluate statistical difference of subjective parameters except halitosis (Fisher’s Exact test) between test and control groups on 0, 7, 14, 21 and 28; and the objective parameters PI and GI were assessed by using Wilcoxon matched pairs test on baseline and the at the end of the trial and the mean values were compared. Results were expressed as mean and standard deviation. A P- value of 0.05 or less was considered for statistical significance.

RESULTS

99 subjects completed the clinical trial, which comprises 75 females and 24 males, with mean age of 35.8 years ranges from 15-55 with mean duration of disease 2.40±3.15 months. The experimental drugs had good acceptance and did not show adverse effects, such as abscess, ulcerations or allergic reactions.
On day 0, the test and control groups did not show statistically significant difference to each other with respect to PI (P=0.1205) and GI (p=0.4785) means p>0.05. These results indicated that both groups were well balanced at baseline (Table 1). At the 28th day, PI mean 0.24 in test and 1.12 in control, GI mean 0.33 in test and 1.70 in control and the difference between them was statistically significant (P<0.001) (Table 1). Mean plaque scores 1.41 to 0.24 (p<0.001) and gingival scores 2.08 to 0.33 (p<0.001) in test group showed that there was a commendable decline after 28th day of treatment, whereas, in control group it was 1.42 to 1.12 (p>0.05) and 2.00 to 1.70 (p>0.05) respectively.
Subjective parameters such as bleeding on probing, swollen gum and bacterial plaque showed significant reduction p<0.01 in both groups, but the test drugs showed precedence over control drugs by exhibiting comparatively quicker response (Tables 2 & 3). The effect on halitosis (Table 04) out of 54 patients 47 (87.38%) were found significant change with complete absence of symptom and no change was observed in 7 (12.62%) patients, there is no significant difference (p=0.4483) in observed between the group.

Table 1. Efficacy of drug in test and control groups on objective parameters. Click here to view full image

Table 2. Efficacy of drug in test group assessed using subjective parameters. Click here to view full image

Table 3. Efficacy of drug in control group using subjective parameters. Click here to view full image

Table 4. Effect on halitosis. Click here to view full image

DISCUSSION

The present study showed that about 9% of the total sample had good oral hygiene, about 76.76% patients from village and 23% from town.
Gingivitis is not a significant threat to the health, but it may develop into periodontitis with permanent destruction of periodontal tissues, which can contribute to illness and cause local and systemic complications. The most common complications are progression to periodontal diseases and tooth loss (Jeyaraj & Chithresan, 2010). Periodontitis and poor oral health in general to an increased risk of heart attack (Mayo Clinic, 2012), strokes (Grau et al., 2004). Women with periodontitis may be more likely to give birth to premature babies or babies with low birth weight than are women with healthy gums (Mayo Clinic, 2012). In recent years, increasing evidence has supported the concept that the relationship between systemic and oral health is bidirectional (Schulze & Busse, 2008; Williams & Offenbacher, 2000).
In this study, the prevalence of disease was found among the females, this finding is in accordance with the studies by Somu et al (2012), Emslie (1966) and Waerhaug (1960) found slightly higher figures for females than in males after the age of twenty, whereas it is highly contrary to the study done by Fruta M et al (2011) have shown that gingivitis is more prevalent in males than in females (Fruta et al., 2011).
High prevalent age groups of this study was 15-30 years, it was mentioned that as the age increases the overall prevalence of gingivitis decreased; this is due to progressive accumulation of the brushing knowledge by the children as they develop (Bhayya et al., 2010).
The effect of the study may be due to the properties posses by the drugs like Punica granatum has astringent, anti inflammatory, strengthen the gum (Ghani, 2010) and antibacterial effect (Salgado et al., 2006). The antibacterial agents present in pomegranate the hydrolysable tannins form complexes of high molecular weight with protein soluble, increase bacterial lysis and moreover, interfere with bacterial adherence mechanisms to tooth surfaces (Salgado et al., 2006). Another study showed that the tannins in the ethanolic extract of the fruit of Punica granatum gel possessed antimicrobial and antibacterial activity in oral infections such as caries, periodontal diseases and stomatitis (Vasconcelos et al., 2006). In the present study, the Punica granatum Linn had prevented plaque formation during the trial, as suggested by Pereira et al (2001) and Kakiuchi et al (1986).
Zizyphus jujuba is a blood purifier (Ghani, 2010), anodyne, astringent and cooling (Chatterjee and Pakrashi, 2010). A study has shown that the essential oil of Z. jujuba seeds has the property of anti inflammation (Al Reza et al., 2010). Rubia cordifolia is an astringent, anti-inflammation, blood purifier and analgesic (Ghani, 2010). A study has shown that the methanolic extract of Rubia cordifolia shows significant analgesic and anti-inflammatory activities (Patel et al., 2010). Borax (alum) is an astringent which helps to arrest bleeding gums. In a study by Putt MS et al (1996) assessed the efficacy of alum containing mouth rinse for properties of reduction of plaque (Amith et al., 2007) (22%) and gingivitis (13%) (Putt et al., 1996). At both 2nd and 4th week examinations, the alum group had lower plaque thickness scores than the placebo group, but neither reduction attained statistical significance. In the present study also the reduction of plaque and gingival bleeding scores from baseline to 28 days were significant.
Quercus infectoria has the properties of astringent, strengthen the teeth and gums, anti-inflammatory and reduce bad breath (Ghani, 2010). Methanolic extract of Quercus infectoria showed minor anti-bacterial, but substantial anti-inflammatory and anti-ulcerogenic activities (Khouzami et al., 2009); and another study showed the extracts of methanol and acetone of Q. infectoria galls exhibited similar antibacterial activity against oral pathogens (Basri et al., 2012); further the extracts is used as traditional medicine in dental powder and in the treatment of toothache & gingivitis (Vermani et al., 2009). The methanolic extract of Piper cubeba has a potential antiulcer effect (Parvez et al., 2010).
Tripala is a traditional Ayurvedic herbal formulation consisting of the dried fruits of three medicinal plants Emblica officinalis, Terminalia belerica and Terminalia chebula (Thomas et al., 2011). It has antibacterial, antiseptic and anti-inflammatory properties (Maurya et al., 1997). Alcoholic extract of Tripala has shown antibacterial, wound healing and antioxidant activities (Kumar et al., 2008), and the methanolic extract of Tripala is incorporated collagen sponge even in fully infected dermal wounds. Salt water has the property to arrest bleeding (Kumar et al., 2010).

CONCLUSION

This study revealed that the test drug has shown precedence over the control drug by effectively reducing the subjective and objective parameters without any adverse effects. Thus, further multicentre randomized standard controlled clinical trials on large sample for longer duration of time are recommended.

ACKNOWLEDGEMENT

Authors are highly thankful to the sponsors of WHO health system research project, Dept. of Community Medicine, University of Colombo; and the management of National Ayurvedic Teaching Hospital, Borella for their support in conducting this clinical trial.

CONFLICT OF INTEREST
None declared.

REFERENCES

Anonymous. A Handbook of Common Remedies in Unani System of Medicine. CCRUM, Ministry of Health & Family Welfare. Govt. of India, Dept. of AYUSH, New Delhi. 27- 28, 2004.
Amith HV, Ankola AV, Nagesh L. Effect of Oil Pulling on Plaque and Gingivitis. Journal of Oral Health Community Dentistry. 2007;1:12-18,.
Al Reza SM, Yoon JI, Kim HJ, Kim JS, Kang SC. Anti-inflammatory Activity of Seed Essential Oil from Zizyphus jujuba. Food and Chemical Toxicology. 2010;48:639-643.
Bhayya DP, Shyagali TR, Mallikarjun K. Study of Oral Hygiene Status and Prevalence of Gingival Diseases in 10-12 year School Children in Maharashtra, India. Journal of International Oral Health. 2010;2:21-25,.
Butler A, Targett D, Bosma ML. Maintenance of Gingival Health- a Measure Based on Clinical Indices. International Dental Journal. 2011;61:28-32,.
Basri DF, Tan LS, Shafiei Z, Zin NM. In vitro antibacterial activity of galls of Quercus infectoria olivier against oral pathogens. Evidence-Based Complementary and Alternative Medicine. 2012:632796.
Chatterjee A, Pakrashi SC. The Treatise on Indian Medicinal Plants. New Delhi: National Institute of Science Communication and Information Resources (CSIR). 2, 3, 4, 163-164, 2010.
Emslie RDA. Dental Health Survey in the Republic of the Sudan. British Dentistry Journal. 1966;120:167-178,.
Fischman SL. The History of Oral Hygiene Products: How far have we come in 6000 years? Periodontology. 2000;15: 7-14, 1997.
Furuta M, Ekuni D, Irie K, Azuma T, Tomofuji T, Ogura T, Morita M. Sex Differences in Gingivitis Relate to Interaction of Oral Health Behaviors in Young People. Journal of Periodontology. 2011;82:558-565.
Grau AJ, Becher H, Ziegler CM, Lichy C, Buggle F, Kaiser C, Lutz R, Bultmann S, Preusch M, Dorfer CE. Periodontal Disease as a Risk Factor for Ischemic Stroke. Journal of the American Heart Association. 2004;35:496-501.
Ghani N. Khazainul Advia. New Delhi: Idara Kitabul Shifa; 271, 419, 950, 951, 1015-1016, 1208- 1209, 1219, 2010.
Mayo Clinic Staff [http://www.mayoclinic.com/health/gingivitis/DS00363/DSECTION=complications] (Accessed on April, 2012).
Jeyaraj JM, Chithresan K. A Randomized Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of HiOra-GA Gum Astringent Gel in Gingivitis. The Antiseptic. 2010;107:441-444.
Kakiuchi N. Studies on dental caries prevention by traditional medicines. VIII. Inhibitory effect of various tannins on glucan synthesis by glucosyltransferase from Streptococcus mutans. Chemical and Pharmaceutical Bulletin. 1986;34:720-725.
Krasse P, Carlsson B, Dahl C, Paulsson A, Nilsson A, Sinkiewicz G. Decreased Gum Bleeding and Reduced Gingivitis by the Probiotic Lactobacillus reuteri. Swedish Dental Journal. 2006;30:55-60.
Kumar MS, Kirubanandan S, Sripriya R, Sehgal PK. Triphala Promote Healing of Infected Full-thickness Dermal Wound. Journal of Surgical Research. 2008;144: 94-101.
Khouzami L, Mroueh M, Daher CF. the Role of Methanolic Extract of Quercus infectoria bark in Lipemia, Glycemia, Gastric Ulcer and Bacterial Growth. Journal of Medicinal Plants Research. 2009;2:224-230.
Kumar MS, Kirubanandan S, Sripriya R, Sehgal PK. Triphala Incorporated Collagen Sponge-A Smart Biomaterial for Infected Dermal Wound Healing. Journal of Surgical Research. 2010;158:162-170.
Kumar V, Abbas AK, Fausto N, Aster JC. Robinson and Cotran Pathological Basis of Disease. 8th ed. Elsevier Publication. 740, 741, 2011.
Lindhe J, Karring T, Lang NP. Clinical Periodontology and Implant Dentistry. 4th ed. 51, 2003.
Maurya DK, Mittal N, Sharma KR, Nath G. Role of Triphala in the Management of Periodontal Disease. Ancient Science of Life. 1997;17: 120–127.
Putt MS, Kleber CJ, Smith CE. Evaluation of an alum-containing mouth rinse in children for plaque and gingivitis inhibition during 4 weeks of supervised use. Pediatric Dentistry. 1996;18:139-44.
Pereira JV, Silva SC, Filho LS, Higino JS. Atividade antimicrobiana do extrato hidroalcoólico da Punica granatum Linn sobre microorganismos formadores de placa bacteriana. Revista Periodontia. 2001;12:57-64.
Patel A, Patel T, Macwan C, Patel M, Chauhan K, Patel J. Evaluation of Anti-inflammatory and Analgesic Activity of Root of Rubia cordifolia in Rats. Journal of Pharmaceutical Sciences & Research. 2010;2:809-813.
Parvez M, Gayasuddin M, Basheer M, Janakiraman K. Screening of Piper cubeba (Linn) fruits for Anti-ulcer activity. International Journal of PharmTech Research. 2010;2:1128-1132.
Sharma N, Charles CH, Lynch MC, Qaqish J, Mcguire JA, Galustians JG et al. Adjunctive Benefit of an Essential Oil-Containing Mouthrinse in Reducing Plaque and Gingivitis in Patients Who Brush and Floss Regularly. Journal of the American Dental Association. 2004;135: 496-504. Salgado ADY, Maia JL, Pereira SLS, Lemos TLG, Mota OML. Antiplaque and Antigingivitis Effects of a Gel Containing Punica granatum linn extract. A Double Blind Clinical Study in Humans. Journal of Applied oral science. 2006;14:162-166.
Salgado ADY, Maia JL, Pereira SLS, Lemos TLG, Mota OML. Antiplaque and Antigingivitis Effects of a Gel Containing Punica granatum linn extract. A Double Blind Clinical Study in Humans. Journal of Applied oral science. 2006;14:162-166. Schulze A, Busse M. Periodontal Disease and Heart Disease. Clinical Sports Medicine International. (CSMI) 2008;1(8):9-12. Somu CA, Ravindra S, Ajith S, Ahamed MG. Efficacy of a herbal extract gel in the treatment of gingivitis: A clinical study. Journal of Ayurveda and Integrative Medicine. 2012;3:85-90.
Schulze A, Busse M. Periodontal Disease and Heart Disease. Clinical Sports Medicine International. (CSMI) 2008;1(8):9-12.
Somu CA, Ravindra S, Ajith S, Ahamed MG. Efficacy of a herbal extract gel in the treatment of gingivitis: A clinical study. Journal of Ayurveda and Integrative Medicine. 2012;3:85-90.
Thomas B, Shetty SY, Vasudeva A, Shetty V. Comparative Evaluation of Antimicrobial Activity of Triphala and Commercially Available Toothpastes: An in-vitro Study. International Journal of Public Health Dentistry. 2011;2:8-12.
Vasconcelos LCS, Sampaio FC, Sampaio MCC, Pereira MSV, Higino JS, Peixoto MHP. Minimum Inhibitory Concentration of Adherence of Punica granatum linn (pomegranate) Gel against S. mutans, S. mitis and C. albicans. Brazilian Dental Journal. 2006;17:223-227.
Vermani A, Navneet, Prabhat. Screening of Quercus infectoria gall extracts as Anti-bacterial agents Against Dental Pathogens. Indian Journal of Dental Research. 2009;20:337-339.
Waerhaug J. Prevalence of Periodontal Disease in Ceylon and its Association with Age, Sex, Oral Hygiene, Socioeconomic Factors, Vitamin Deficencies, Malnutrition, Betel and Tobacco Consumption and Ethnic Groups. Acta Odontologica Scandinavica.1967;25:205-230.
Williams RC, Offenbacher S. Periodontal Medicine: The Emergence of a New Branch of Periodontology. Periodontology. 23, 9-12, 2000.
Williamson ME. Major Herbs of Ayurveda. China: Churchill Livingston. 239-42, 257-59, 2002.