A Randomized, Double-Blind, Placebo-Controlled Trial on Clinical Efficacy of Topical Agents in Reducing Pain and Frequency of Recurrent Aphthous Ulcers

TODENTJ-25-03-2019_TODENTJ-12-700 1553507506 Bentham Open doi@benthamopen.net Bentham Open The Open Dentistry Journal TODENTJ 1874-2106 09 28 2018 12 1 A Randomized, Double-Blind, Placebo-Controlled Trial on Clinical Efficacy of Topical Agents in Reducing Pain and Frequency of Recurrent Aphthous Ulcers Renu Sharma Shambulingappa Pallagatti Amit Aggarwal Soheyl Sheikh Ravinder Singh Deepak Gupta Introduction: Recurrent Aphthous Ulcers (RAU) is one of the most common oral ulcerative Disease of the oral mucosa with high recurrence rate. Standard topical treatment options provide symptomatic relief with few have been found to be effective in treating or relieving the symptoms. Aim: The study aimed to evaluate the clinical efficacy of various topical agents in order to find the better treatment modality so as to decrease the number, size, exudate level and discomfort associated with pain with RAU. Materials and methods: The patients diagnosed with minor recurrent aphthous ulcers fulfilling the inclusion and exclusion criteria were enrolled. All the baseline parameters were measured by the principal investigator. The treatment modality was assigned by generating a randomization list by computer software, double-blinded in consecutively numbered sealed envelopes. The topical treatment modalities that were included: 5% Amlexanox, 0.1% Triamcinolone Acetonide, 20% Benzocaine gel, 100 mg Doxycycline hyclatemixed with denture adhesive and normal saline (20:2:1); The study was placebo controlled in which placebo gel 10 gm was used. The size, no of ulcers, pain, erythema and exudate level were measured by the principal investigator at days 1, 4, 8 and 10. All quantitative variables were estimated using measures of central tendency (mean, median) and measures of dispersion (standard deviation). Qualitative or categorical variables were described as frequencies or proportions. Proportions were compared using Post Hoc Test and N Par Tests. Effectiveness was checked using p-value (< 0.005). Results: It was observed that 0.1% Triamcinolone Acetonide and 5% Amlexanox proven to be more efficacious in the reduction of size, Number, Pain, Erythema and Exudate Levels at day 8, (p = .000*) and at day 10 (p =. 000*) as compared to single application of 100 mg Doxycycline Hyclate, 20% Benzocaine gel and the placebo, which was statistically significant. VAS scale was significant for 100 mg Doxycycline Hyclate and 20% Benzocaine gel. Conclusion: The selected topical treatment modality can deliver cheap, effective and safe drug therapy which benefits the patient in refining their regular activities and everyday events of life. 09 28 2018 700 713 TODENTJ-12-700 1 10.2174/crossmark_policy opendentistryjournal.com benthamopen.com true Peer Reviewed Single blind Checked with iThenticate 2018-5-3 2018-8-13 2018-9-4 2018-09-28 https://creativecommons.org/licenses/by/4.0/legalcode 10.2174/1745017901814010700 1553507506 https://opendentistryjournal.com/VOLUME/12/PAGE/700/ https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.pdf https://opendentistryjournal.com/contents/volumes/V12/TODENTJ-12-700/TODENTJ-12-700.xml Aust. Dent. J. Vucicevic B V. 52 10 2007 10.1111/j.1834-7819.2007.tb00459.x Vucicevic B V, Savage NW. Recurrent aphthous ulcerative disease: Presentation and management. Aust Dent J 2007; 52 (1) : 10-5. Dtsch. Arztebl. Int. Altenburg A. 111 665 2014 Altenburg A, El-Haj N, Micheli C, Puttkammer M, Abdel-Naser MB, Zouboulis CC. The treatment of chronic recurrent oral aphthous ulcers. Dtsch Arztebl Int 2014; 111 (40) : 665-73. J. Clin. Aesthet. Dermatol. Edgar N.R. 10 26 2017 Edgar NR, Saleh D, Miller RA. Recurrent aphthous stomatitis: A review. J Clin Aesthet Dermatol 2017; 10 (3) : 26-36. Clinics (São Paulo) Gallo Cde.B. 64 645 2009 10.1590/S1807-59322009000700007 Gallo CdeB, Mimura MA, Sugaya NN. Psychological stress and recurrent aphthous stomatitis. Clinics (São Paulo) 2009; 64 (7) : 645-8. Int. J. Oral Maxillofac. Surg. Natah S.S. 33 221 2004 10.1006/ijom.2002.0446 Natah SS, Konttinen YT, Enattah NS, Ashammakhi N, Sharkey KA, Häyrinen-Immonen R. Recurrent aphthous ulcers today: A review of the growing knowledge. Int J Oral Maxillofac Surg 2004; 33 (3) : 221-34. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Vijayabala G.S. 116 440 2013 10.1016/j.oooo.2013.06.015 Vijayabala GS, Kalappanavar AN, Annigeri RG, Sudarshan R, Shettar SS. Single application of topical doxycycline hyclate in the management of recurrent aphthous stomatitis. Oral Surg Oral Med Oral Pathol Oral Radiol 2013; 116 (4) : 440-6. Dermatol Therap Scully C. 15 185 2002 Scully C, Gorsky M, Nur LF. Aphthous ulcerations. Dermatol Therap 2002; 15 (3) : 185-205. J. Eur. Acad. Dermatol. Venereol. Altenburg A. 21 1019 2007 10.1111/j.1468-3083.2007.02393.x Altenburg A, Abdel-Naser MB, Seeber H, Abdallah M, Zouboulis CC. Practical aspects of management of recurrent aphthous stomatitis. J Eur Acad Dermatol Venereol 2007; 21 (8) : 1019-26. Int J Cur Res Rev Arun M.K. 6 16 2014 Arun MK, Ananthakrishnan V, Goturu J. Etiology and pathophysiology of recurrent aphthous stomatitis: A review. Int J Cur Res Rev 2014; 6 (10) : 16-22. Arch. Dermatol. Thornhill M.H. 143 463 2007 10.1001/archderm.143.4.463 Thornhill MH, Baccaglini L, Theaker E, Pemberton MN. A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis. Arch Dermatol 2007; 143 (4) : 463-70. Chron Young Sci Angeline Archana J.P. 2 134 2011 10.4103/2229-5186.90889 Angeline Archana JP. Jesudoss Prabhakaran AC. Pharmacotherapy of recurrent aphthous ulcers. Chron Young Sci 2011; 2 : 134-8. Aust. Dent. J. Vucicevic Boras V. 52 10 2007 10.1111/j.1834-7819.2007.tb00459.x Vucicevic Boras V, Savage NW. Recurrent aphthous ulcerative disease: Presentation and management. Aust Dent J 2007; 52 (1) : 10-5. J. Am. Board Fam. Med. Volkov I. 22 9 2009 10.3122/jabfm.2009.01.080113 Volkov I, Rudoy I, Freud T, et al. Effectiveness of vitamin B12 in treating recurrent aphthous stomatitis: A randomized, double-blind, placebo-controlled trial. J Am Board Fam Med 2009; 22 (1) : 9-16. Crit. Rev. Oral Biol. Med. Porter S.R. 9 306 1998 10.1177/10454411980090030401 Porter SR, Scully C, Pedersen A. Recurrent aphthous stomatitis. Crit Rev Oral Biol Med 1998; 9 (3) : 306-21. Cutis Eisen D. 68 201 2001 Eisen D, Lynch DP. Selecting topical and systemic agents for recurrent aphthous stomatitis. Cutis 2001; 68 (3) : 201-6. J. Am. Dent. Assoc. Scully C. 134 200 2003 10.14219/jada.archive.2003.0134 Scully C, Gorsky M, Lozada-Nur F. The diagnosis and management of recurrent aphthous stomatitis: A consensus approach. J Am Dent Assoc 2003; 134 (2) : 200-7. J. Int. Oral Health Tarakji B. 7 74 2015 Tarakji B, Gazal G, Al-Maweri SA, Azzeghaiby SN, Alaizari N. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health 2015; 7 (5) : 74-80. ChemIDplus Chemical Information Classification. https://chem.sis.nlm.nih.gov /chemidplus/chemidheavy.jsp Dtsch. Arztebl. Int. Altenburg A. 111 665 2014 Altenburg A, El-Haj N, Micheli C, Puttkammer M, Abdel-Naser MB, Zouboulis CC. The treatment of chronic recurrent oral aphthous ulcers. Dtsch Arztebl Int 2014; 111 (40) : 665-73. Scientific World J Alves VF 7 2015 10.1155/2015/150412 Alves VF, Stella MM, Campos SAF, Muller RK. Low-level laser therapy in the treatment of recurrent aphthous ulcers: A systematic review. Scientific World J 2015; 7. Am. J. Health Syst. Pharm. Barrons R.W. 58 41 2001 Barrons RW. Treatment strategies for recurrent oral aphthous ulcers. Am J Health Syst Pharm 2001; 58 (1) : 41-50. J. Pharm. Biomed. Sci. Sree V.G. 30 40 2011 Sree VG, Kalappanavar AN, Annigeri RG, Ramachandran S. Past and present concepts in the management of recurrent aphthous ulcers: A review. J Pharm Biomed Sci 2011; 30 (30) : 40-9. J. Clin. Exp. Dent. Belenguer-Guallar I. 6 e168 2014 10.4317/jced.51401 Belenguer-Guallar I, Jiménez-Soriano Y, Claramunt-Lozano A. Treatment of recurrent aphthous stomatitis. A literature review. J Clin Exp Dent 2014; 6 (2) : e168-74. Dent. Clin. North Am. Akintoye S.O. 58 281 2014 10.1016/j.cden.2013.12.002 Akintoye SO, Greenberg MS. Recurrent aphthous stomatitis. Dent Clin North Am 2014; 58 (2) : 281-97.