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RESEARCH ARTICLE The efficacy of amlexanox and triamcinolone acetonide in the treatment of recurrent aphthous ulcers. Satish Balwani Department of Oral Pathology and Microbiology, Dr. Rajesh Ramdasji Kambe Dental College and Hospital, Akola, Maharashtra, India. Abstract Background: Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease characterised by chronic, ulcerative condition of the oral mucosa. Material and Methods: In this study we compared the efficacy of 5% Amlexanox with 0.1% Triamcinolone Acetonide in patients with RAS for pain relief and healing time. The patients were principally divided into 2 study groups, 30 in each group. Group A were treated by 5% Amlexanox, and Group B were given 0.1% Triamcinolone acetonide, topical application on the ulcer 3 times a day for 7 days. Results: The mean value of pain scores on the days after the treatment from the first day to the seventh day was significantly higher in amlexanox group than triamcinolone acetonide group (푃 ≤ 0.05). The time of complete healing of ulcers was recorded in amlexanox group, the mean healing time of ulcers, reported by these 24 patients, was 4.17 ± 1.80 days (range 4-7). In triamcinolone acetonide group, the mean healing time of ulcers, reported by 30 patients with healed ulcers, was 2.24 ± 1.36 days (range 2-4). The difference was statistically significant (푃 ≤ 0.05). Conclusion: Both amlexanox and triamcinolone acetonide are effective and safe in the treatment of aphthous ulcers. Key words: Recurrent aphthous stomatitis, Amlexanox, triamcinolone acetonide, oral ulcer. term and later it was described by Mikulicz and Kummel as ‘Mikulicz’s aphthae.’ It is Introduction more common in patients between 10-40 Recurrent aphthous stomatitis (RAS) years of age.2 is the most common oral mucosal disease RAS is classified into 3 types, minor, characterised by chronic, ulcerative major, and herpetiform aphthous ulcerations condition of the oral mucosa without a fully according to the diameter of the lesion. recognized etiology. The term “aphthous” is Minor RAS, which comprisesmore than derived from a Greek word “aphthae” which 80%-90% of RAS cases, presents lesions of means ulceration.1 Hippocrates used this less than 1cm in diameter and heals within JoJournal of Advanced Health Sciences and Research |January - June 2020 | Vol 1 |Issue 1 Page 9 RESEARCH ARTICLE 7-14 days without scar formation. Major so on. However, the etiology of this illness is RAS lesions exceed 1cm in diameter and unknown.7, 8 heal within 20-30 days with scarring. RAS is a difficult disorder to treat. Herpetiform ulcers are characterized by There is no definite treatment for RAS and recurrent crops of dozens of small ulcers supportive treatment is performed aiming to throughout the oral mucosa, 1-3mm, which control pain, accelerate healing and prevent may coalesce into larger ulcers and heal up recurrence.9 All therapies are aimed to to 15 day.3, 4 decrease the painful symptoms and RAS is characterized by the duration of the ulcers.10 Topical or systemic presence of painful, oval erosions or ulcers antibacterial such us chlorhexidine, anti- generally localized on the unattached oral inflammatory, immunomodulatory, or mucosa of the lips, cheeks and tongue, symptomatic treatments are used however which are surrounded by an erythematous such treatments are not totally reliable.11 halo. Nearly 5-25 % of the population is Since the cause of the disease is not affected by RAS and more frequent in the known, many drugs have been evaluated in age range of 10-40 years. It is a an attempt to palliate the symptoms. Drugs multifactorial disease and several used in the treatment of RAU are systemic predisposing and risk factors have been corticosteroids, pentoxifylline, colchicine, implicated in its pathogenesis. dapsone, thalidomide, low-dose interferon-α Etiopathogenesis remains poorly and levamisole.12 In this study we compared understood despite their high prevalence.5 the efficacy of 5% Amlexanox with 0.1% The exact pathogenesis of RAU remains Triamcinolone Acetonide in patients with unknown. Various causes of RAU have RAS for pain relief and healing time. been reported in several studies and include genetic predisposition, drugs, foods, the Material and Methods presence of certain oral microbial communities, immunological factors, The patients who visited our dental endocrinopathies, and psychological and hospital with a complaint of recurrent oral hereditary factors.6 Different studies have aphthous ulcers less than 1cm in diameter introduced different factors affecting the on the first day of the occurrence of the disease such as, immune disorders, ulcer and between ages of 20 and 40 were hormonal changes, vitamin deficiency and included in the study. Patients willing to participate in the study and with clinically JoJournal of Advanced Health Sciences and Research |January - June 2020 | Vol 1 |Issue 1 Page 10 RESEARCH ARTICLE diagnosed minor RAS noticed within 2 days the treatment the pain severity and healing of development of ulcer were included in the time of the ulcer was evaluated on the first, study. Patients having major RAS, traumatic fourth, and the seventh day. Data were ulcer, denture stomatitis or suffering from analyzed using SPSS 16 and t-test. The any systemic illness, patients under any statistically significant level was accepted as medication (topical or systemic), and dental a 푃 value <0.05. surgery during the previous one month were excluded. Pregnant or lactating women Results were also excluded from the study. The study group consisted of 48 The current study included in all 60 men and 12 women with an average age of healthy patients suffering with RAS, with an 23.52±3.50 years (20-40 years). Thirty age group from 20 years and above. The patients received the amlexanox ointment patients were principally divided into 2 study and 30 patients received triamcinolone groups, 30 in each group. Group A were acetonide ointment. Table 1 shows the treated by 5% Amlexanox (Trade name- mean value of pain scores at admission and Lexanox), and Group B were given 0.1% on the days after the treatment. The mean Triamcinolone acetonide (Trade name- value of pain scores before the treatment Kenacort), topical application on the ulcer 3 was similar in both of the groups (푃 = times a day for 7 days. Both the groups 0.832).The mean value of pain scores on were followed up on the first, fourth and the days after the treatment from the first seventh day. Written informed consent was day to the seventh day was significantly obtained from all patients. Also ethical higher in amlexanox group than committee clearance was obtained from triamcinolone acetonide group (푃 ≤ 0.05). Institutional Ethics Committee. On the seventh day after the Changes in pain scores, healing treatment, the ulcers were completely time, and side effects of the treatment were reepithelialized in 24 patients (68.5%) in evaluated. At admission the patients were amlexanox group and in 30 patients (85.7%) asked to evaluate the severity of pain by in triamcinolone acetonide group. The visual analog scale (VAS). Pain was difference was statistically significant (푃 ≤ numerically valued from 0 to 10 using visual 0.05). Furthermore, the time of complete analog scale (VAS). For patients, the healing of ulcers was recorded in number 0 and 10 were considered as no pain and the worst pain, respectively.After JoJournal of Advanced Health Sciences and Research |January - June 2020 | Vol 1 |Issue 1 Page 11 RESEARCH ARTICLE Table1: Comparison of VAS score for the 7 Amlexanox and Triamcinolone acetonide groups 6 in different days 5 Before Day 1 Day 4 Day 7 4 the treatm 3 ent Healing Time 2 Amlexanox 8.65 ± 7.25 ± 5.10 ± 1.55 ± Group 0.45 0.57 0.38 0.27 1 Triamcinol 8.80 ± 6.70 ± 4.35 ± 1.30 ± 0 one 0.32 0.28 0.20 0.52 Amlexanox Triamcinolone acetonide acetonide Group Group P value 0.832 0.275 0.0488 0.040 Figure1: The mean healing time in ulcers in amlexanox group and triamcinolone acetonide amlexanox group, the mean healing time of group. ulcers, reported by these 24 patients, was Therefore, first choice of treatment for RAS 4.17 ± 1.80 days (range 4-7). In patients is corticosteroids and analgesics. triamcinolone acetonide group, the mean Topical treatments are preferred over healing time of ulcers, reported by 30 systemic therapy due to fewer side effects patients with healed ulcers, was 2.24 ± 1.36 days (range 2-4). The difference was The present study evaluated the statistically significant (푃 ≤ 0.05)(Figure 1). effect of amlexanox and triamcinolone Additionally, no patient reported any side acetonide in the treatment of recurrent effects from either of the groups. aphthous stomatitis, pain severity and healing process on the first, fourth and seventh days of study. A total of 60 subjects Discussion were analyzed in the present study. The Recurrent aphthous ulcer (RAU) is mean value of pain scores on the days after one of the most common ulcerative the treatment from the first day to the diseases affecting the oral mucous seventh day was significantly higher in membrane. RAS is a difficult disorder to amlexanox group than triamcinolone treat. Symptomatic and supportive acetonide group (푃 ≤ 0.05). Sharma R et 13 treatment should be provided initially. al showed that 0.1% Triamcinolone Acetonide and 5% Amlexanox is more JoJournal of Advanced Health Sciences and Research |January - June 2020 | Vol 1 |Issue 1 Page 12 RESEARCH ARTICLE efficacious in the reduction of size, Number 5% of Amlexanox oral paste is and Pain at day 8 and at day 10 as clinically beneficial in reducing the pain, compared to single application of 20% erythema, exudation and size of the ulcer Benzocaine gel, 100 mg Doxycycline over a period of 6 days.