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Efficacy of G32 in Treating Pregnancy Gingivitis a Randomised Controlled Trial

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Efficacy of G32 in Treating Pregnancy Gingivitis a Randomised Controlled Trial Published online in http://ijam.co.in ISSN: 0976-5921 International Journal of Ayurvedic Medicine, 2013, 4(1), 50-58 Efficacy of G32 in Treating Pregnancy Gingivitis A Randomised Controlled Trial Research Article Hathiwala S1*, Acharya S2, Bhat PV3, Patil S1 1. Post Graduate, 2. Professor and Head of Department, Dept. of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, Karnataka, 3. Professor and Head of Department, Dept. of Obstetrics and Gynaecology, Maleka Manipal Medical College, Manipal, Karnataka, India Abstract Background: Pregnant females are susceptible to oral conditions like gingivitis and pregnancy tumour, which affect both the mother and the developing foetus. Chlorhexidine, conventionally used to treat these conditions, causes side effects on long term use. Ayurvedic medications like G32 have been used for treating gingivitis. Objective: To compare efficacy of G32 with Chlorhexidine in treating pregnancy gingivitis after topical application. Materials and Methods: This was a double blind, randomised controlled trial conducted in a sample of 37 pregnant females, in second trimester, with gingivitis. They were randomly divided into two groups and were allotted Chlorhexidine gel (n=18) or G32 gum- paint (n=19) for local application for one month. Plaque index (Silness and Löe, 1964) and Gingival index (Löe and Silness, 1963) were recorded at baseline and follow-up by a calibrated examiner. Statistical analysis was performed using paired t-test for intragroup comparison of mean plaque and gingival scores, and independent t-test for intergroup comparison of mean percentage reduction in plaque and gingival scores. Results: Both test and control groups showed a significant reduction in plaque and gingivitis. The percentage reductions in plaque and gingivitis were similar among the two groups. Conclusion: G32 is effective in treating pregnancy gingivitis and can be economical alternative to Chlorhexidine, with lesser side effects. Keywords: Ayurvedic, Pregnancy, Gingivitis, Chlorhexidine, G32, Trial Introduction: end results of complex hormonal, Pregnancy has far-reaching immunologic, dietary, and behavioural systemic effects extending beyond the changes occurring during pregnancy (1). reproductive organs. These effects are the These can include changes in the cardiovascular, respiratory and *Corresponding Author: gastrointestinal systems, as well as Hathiwala S changes in the oral cavity and increased Post Graduate (MDS), susceptibility to oral infection (2). The oral Dept. of Public Health Dentistry, effects are primarily seen as gingival Manipal College of Dental Sciences, manifestations; mainly causing pregnancy- Manipal associated gingivitis and pyogenic Karnataka, India granuloma or pregnancy tumour. So E-mail: [email protected] maintaining a good oral health is important Ph.No: +91 9741544482 during pregnancy. 50 Published online in http://ijam.co.in ISSN: 0976-5921 Hathiwala S et.al., Efficacy of G32 in treating Pregnancy Gingivitis – a Randomized Controlled Trial The occurrence of pregnancy the first trimester. Any treatment should be gingivitis has been acknowledged for a directed toward controlling disease, substantial period of time. The term was maintaining a healthy oral environment first described in 1877 (3), although and preventing potential problems that descriptions of the condition had been could occur later in pregnancy or during given even earlier in 1840 (4). It is the postpartum period. extremely common and affects 30-75% of Nevertheless, a treatment for all pregnant women (5, 6). gingivitis is definitely needed, as the lack Gingival inflammatory changes in of care of gums and teeth affects both the pregnancy usually begin during the second mother and the foetus. Severe gingival month and increase in severity through the disease during pregnancy and the eighth month, after which an abrupt periodontal disease, which progresses from decrease occurs in the symptoms (7, 8). untreated gingivitis, can lead to premature The greatest involvement appears to be in delivery and low birth weight of the baby gingivae of the anterior teeth, with (10, 11). Thorough oral hygiene measures, interproximal sites most commonly including tooth brushing and flossing, are affected (9). The interproximal papillae recommended to prevent occurrence of become red, oedematous and tender to these diseases. Patients with severe palpation, and they bleed easily if gingivitis may require professional subjected to trauma (2). Various studies cleaning, along with mouth rinses like have confirmed that the prevalence and Chlorhexidine. More severe cases, if do severity of gingival inflammation is not regress, need surgical therapy (12) significantly higher in pregnant women which is not advisable during pregnancy. compared to postpartum, and appears So the non-surgical treatment is the best unrelated to the amount of plaque present. approach. Also pre-existing gingivitis or Chlorhexidine is a known periodontitis in pregnant women has been therapeutic agent used for treating noted to worsen dramatically (9). gingivitis in general and also in pregnancy Even a healthy pregnancy causes gingivitis. It is a dicationic bisguanide with major changes in maternal anatomy, pronounced antiseptic, antibacterial, physiology and metabolism. These patients antifungal and antiplaque properties. It is have a heightened awareness of and available as oral rinse (0.2% and 0.12%) sensitivity to taste, smell and and gel (1%). Many studies have shown environmental temperature. Unpleasant that the long term use of Chlorhexidine tastes and odours can cause severe nausea may cause side effects ranging from as or even gagging and vomiting (2). mild as staining of oral surfaces, such as Although these adaptations of maternal tooth surfaces, restorations, and the body are normal, they do necessitate dorsum of the tongue and a transient consideration and adjustments in treatment alteration in taste perception, to as severe by any dentist, who is providing oral as hypersensitivity, generalized allergic health care and prescribing medications for reactions and oro-pharyngeal cancer (13). the patient. High content of alcohol (12%) in this Routine general dentistry should be product has been a point of concern for use done in the second trimester of pregnancy in pregnancy and so it has been placed only, due to organogenesis occurring under category ‘B’ for usage in pregnant during the first trimester and increased females (14). uterine size in the third trimester, making Under such circumstances, it has sitting in the dental chair uncomfortable. become vital to explore safe alternatives to Also nausea generally ceases by the end of Chlorhexidine. Many ayurvedic 51 Published online in http://ijam.co.in ISSN: 0976-5921 International Journal of Ayurvedic Medicine, 2013, 4(1), 50-58 formulations have been tested and have Pipala ni Lakh (Ficus - 10 mg. been proved to be effective in treating religiosa) gingival diseases, with fewer deleterious Samudrafin (Os sapiae) - 10 mg. effects. Many formulations like Salvadora Vajradanti (Barleria prioitis) - 10 mg. persica (Miswak), Triphala, Propolis, Taj (Cinnamimum cassia) - 5 mg. Azadirachta indica (Neem) have been Mari (Piper nigrum) - 5 mg. widely used (15-18). Sajikhar (Sodium carbonate - 5 mg. G32, used in this study, is one such impure) ayurvedic preparation. It is available for Kulinjan (Alpinia chinensis) - 5 mg. local application, in an easily crushable Pipar (Piper longum) - 5 mg. tablet form and as gum paint. The main Kapur (Camphora - 5 mg. ingredients in this ayurvedic preparation officinarum) include Bakul, Chok, Katha, Laving, Kuth (Uncaria gambier) - 5 mg. Fatakdi, etc. (Appendix A). It has anti- inflammatory, antiseptic, antibacterial, Objectives: astringent, anodyne, styptic and healing To evaluate the effectiveness of G32 actions. Various studies have shown it to gum-paint in reducing dental plaque be effective in treating gingivitis (19-21) and gingivitis in pregnant females. and pregnancy-induced gingivitis (22). To compare its effectiveness with These studies have shown that it has Chlorhexidine gel. minimal side effects and has good compliance of the patients. However, no Materials and methods: studies have been conducted till this date This was a parallel design, that compare G32 with Chlorhexidine, the randomised controlled trial, conducted on existing ‘gold standard’ for gingivitis (23). pregnant females with gingivitis, in their So this study was conducted with an aim second trimester. The examinations were to compare the effectiveness of ayurvedic performed in the Ante-natal formulation, G32 with Chlorhexidine in Gynaecological clinics of Dr. T.M.A. Pai treating pregnancy gingivitis. Hospital, Udupi (Karnataka, India). The study was approved by the Kasturba Constituents of G32 (19-22) Hospital Institutional Ethics Committee, Bakul (Mimosops elangi) - 80 mg. Manipal (IEC 82/2011). An informed Chok (Calcium Carbonate) - 75 mg. consent was taken from all the study Katho (Acacia catechu) - 40 mg. participants before their inclusion. Laving (Myrtus - 20 mg. caryophyllus) Sample selection – Chikani Sopari (Areca - 20 mg. The pregnant females, aged 20-35 catechu) years, who were in their second Fatakadi (Alumen) - 20 mg. trimester and had signs of moderate to Mayafal (Quercus infectoria) - 20 mg. severe gingivitis, with or without Elaichi (Elettaria - 10 mg. plaque or debris, were included in the cardamomum) study. Sonageru (Silicate of - 10 mg. Those who had medical
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