A comparative evaluation of the efficacy of herbal mucoadhesive patch with benzocaine mucoadhesive patch to relieve pain associated with placement of elastomeric separators.
DOI:
https://doi.org/10.69980/ajpr.v28i5.372Abstract
Aims: The Purpose of this study was to evaluate the efficacy of benzocaine and herbal mucoadhesive patch in reducing pain caused by elastomeric separators.
Materials and methods: A sample size of 40 patients were selected for the study. Elastomeric separators were placed mesial and distal to first maxillary molars in both quadrants and the patches were placed buccal mucosa above the 1st maxillary molars. The medication patch and the placebo patch were distributed randomly among the two groups of 20 patients each. For both of their first maxillary molars, the patients were given Visual Analogue Scales (VAS). The Mann-Whitney U test and Krausal test analyses were done after data collection. The patient recorded readings every six hours beginning 30 minutes after the patch insertion. The mucoadhesive drug and placebo patch was replaced after 48 hours and every six hours, the reading was remarked, and the final marking was conducted at 72nd hour and mucoadhesive patch was replaced.
Results: There was statistically significant reduction in pain. when mucoadhesive drug patch was compared with the placebo patch. It was seen that benzocaine was most effective at 6th, 48th ,72nd hour, followed by quercetin patch which was effective at 6th, 48th ,72nd hour. When two drug patches were compared it was observed that benzocaine was significantly effective in relieving pain caused due to separators.
Conclusion: It can be concluded from the study that benzocaine and quercetin patches were effective in reducing pain caused by elastomeric separators as compared to the placebo patch. The use of benzocaine patches was most effective followed by a quercetin mucoadhesive patch.
References
1. Tortamano A, Lenzi DC, Haddad ACSS, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofac Orthop Off Publ Am Assoc Orthod Its Const Soc Am Board Orthod. 2009 Nov;136(5):662–7.
2. Nicotra C, Polizzi A, Zappalà G, Leonida A, Indelicato F, Caccianiga G. A Comparative Assessment of Pain Caused by the Placement of Banded Orthodontic Appliances with and without Low-Level Laser Therapy: A Randomized Controlled Prospective Study. Dent J. 2020 Mar 4;8(1):24.
3. Vallakati A, Jyothikiran H, Shanthraj R, Patel P. Orthodontic separators – a systemic review. J Orofac Health Sci. 2014 Jan;5(3):118.
4. Malagan MA, P P B, Muddaiah S, Reddy R, Shetty BK, Preetham J, et al. Comparison between efficacy of four different types of orthodontic separators. J Clin Diagn Res JCDR. 2014 Aug;8(8):41-44.
5. Eliades T, Brantley WA. Orthodontic applications of biomaterials: a clinical guide. Amsterdam: Elsevier; 2017.
2. Bondemark L, Fredriksson K, Ilros S. Separation effect and perception of pain and discomfort from two types of orthodontic separators. World J Orthod. 2004 Summer;5(2):172-6.
3. Hoffman WE. A study of four types of orthodontic separator. Am J Orthod. 1972 Jul;62(1):67–73.
4. Paul R, Yadav D, Gupta M, Gulia V, Babra S. A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study. Eur Chem Bull. 2024;12(special issue 4):5800–8.
5. Shenoy N, Shetty S, Ahmed J, Shenoy K A. The pain management in orthodontics. J Clin Diagn Res. 2013 Jun;7(6):1258-60.
6. Beck VJ, Farella M, Chandler NP, Kieser JA, Thomson WM. Factors associated with pain induced by orthodontic separators. J Oral Rehabil. 2014 Apr;41(4):282–8.
7. Simpson DM, Messina J, Xie F, Hale M. Fentanyl buccal tablet for the relief of breakthrough pain in opioid-tolerant adult patients with chronic neuropathic pain: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2007 Apr;29(4):588-601.
8. Chandrashekar A, Annigeri RG, Thimmasetty J. Comparative evaluation of diclofenac and meloxicam as tablets and as transmucosal mucoadhesive patches in dental pain reduction. Int J Pharm Sci Res. 2020 May 1;11(5):2217-22.
9. Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, et al. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017 Jan 19;26(1):16.
10. Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8.
11. McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19.
12. Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med Off J Soc Acad Emerg Med. 2001 Dec;8(12):1153–7.
13. Keim RG. Managing orthodontic pain. J Clin Orthod. 2004 Dec;38(12):641-2.
14. Kubo K. Advancements in Pharmaceutical Chemistry: Innovations in Drug Discovery and Development. Res Rev J Pharm Anal. 2024 Sep 23;13(3):1–2.
15. Shemer A, Amichai B, Trau H, Nathansohn N, Mizrahi B, Domb AJ. Efficacy of a mucoadhesive patch compared with an oral solution for treatment of aphthous stomatitis. Drugs R D. 2008;9(1):29-35.
16. Shaikh R, Raj Singh TR, Garland MJ, Woolfson AD, Donnelly RF. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci. 2011 Jan;3(1):89-100.
17. Jacob S, Nair AB, Boddu SHS, Gorain B, Sreeharsha N, Shah J. An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems. Pharmaceutics. 2021 Aug 5;13(8):1206.
18. Ezike TC, Okpala US, Onoja UL, Nwike CP, Ezeako EC, Okpara OJ, et al. Advances in drug delivery systems, challenges and future directions. Heliyon. 2023 Jun 24;9(6):e17488.
19. Sudhakar Y, Kuotsu K, Bandyopadhyay AK. Buccal bioadhesive drug delivery — A promising option for orally less efficient drugs. J Controlled Release. 2006 Aug 10;114(1):15–40.
20. Colley HE, Said Z, Santocildes-Romero ME, Baker SR, D’Apice K, Hansen J, et al. Pre-clinical evaluation of novel mucoadhesive bilayer patches for local delivery of clobetasol-17-propionate to the oral mucosa. Biomaterials. 2018 Sep 1;178:134–46.
21. Gilhotra RM, Ikram M, Srivastava S, Gilhotra N. A clinical perspective on mucoadhesive buccal drug delivery systems. J Biomed Res. 2014 Mar;28(2):81–97.
22. Yang X, Wei X, Mu Y, Li Q, Liu J. A review of the mechanism of the central analgesic effect of lidocaine. Medicine (Baltimore). 2020 Apr 24;99(17):e19898.
23. Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec 31;16(4):237.
24. Maestrelli F, Capasso G, González-Rodríguez ML, Rabasco AM, Ghelardini C, Mura P. Effect of preparation technique on the properties and in vivo efficacy of benzocaine-loaded ethosomes. J Liposome Res. 2009;19(4):253-60.
25. Corega C, Vaida L, Festila DG, Rigoni G, Albanese M, D’Agostino A, et al. The benefits of Quercitin for dentistry and maxillofacial surgery: a systematic review. Minerva Stomatol. 2014 Jan;63(1-2):43-9.
26. Mirza MA, Mahmood S, Hilles AR, Ali A, Khan MZ, Zaidi SAA, et al. Quercetin as a Therapeutic Product: Evaluation of Its Pharmacological Action and Clinical Applications-A Review. Pharm Basel Switz. 2023 Nov 20;16(11):1631.
27. Jones M, Chan C. The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical trial of two initial aligning arch wires. Am J Orthod Dentofacial Orthop. 1992 Oct;102(4):373-81.
28. Primosch RE, Rolland-Asensi G. Comparison of topical EMLA 5% oral adhesive to benzocaine 20% on the pain experienced during palatal anesthetic infiltration in children. Pediatr Dent. 2001 Jan-Feb;23(1):11-4.
29. Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.
30. Kluemper GT, Hiser DG, Rayens MK, Jay MJ. Efficacy of a wax containing benzocaine in the relief of oral mucosal pain caused by orthodontic appliances. Am J Orthod Dentofac Orthop Off Publ Am Assoc Orthod Its Const Soc Am Board Orthod. 2002 Oct;122(4):359–65.
31. Wu SJ, Julliard K. Children's preference of benzocaine gel versus the lidocaine patch. Pediatr Dent. 2003 Jul-Aug;25(4):401-5.
32. Nusstein JM, Beck M. Effectiveness of 20% benzocaine as a topical anesthetic for intraoral injections. Anesth Prog. 2003;50(4):159-63.
33. Hersh EV, DeRossi SS, Ciarrocca KN, Secreto SA, Ghassemi A. Efficacy and tolerability of an intraoral benzocaine patch in the relief of spontaneous toothache pain. J Clin Dent. 2003;14(1):1-6.
34. Hersh EV, Stoopler ET, Secreto SA, DeRossi SS. A study of benzocaine gel dosing for toothache. J Clin Dent. 2005;16(4):103-8.
35. Giannopoulou C, Dudic A, Kiliaridis S. Pain discomfort and crevicular fluid changes induced by orthodontic elastic separators in children. J Pain. 2006 May;7(5):367–76.
36. Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20.
37. Nalbantgil D, Cakan DG, Oztoprak MO, Arun T. Perception of pain and discomfort during tooth separation. Aust Orthod J. 2009 Nov;25(2):110–5.
38. Patel RP, Patel G, Patel H, Baria A. Formulation and evaluation of transdermal patch of aceclofenac. Research Journal of Pharmaceutical Dosage Forms and Technology. 2009;1(2):108-15.
39. Bhaskar H, Kapoor P, Ragini. Comparison of transdermal diclofenac patch with oral diclofenac as an analgesic modality following multiple premolar extractions in orthodontic patients: A cross over efficacy trial. Contemp Clin Dent. 2010 Jul;1(3):158-63.
40. Habib, F., Shaltout, S., Azeem, M., Fetih, G., Safwat, M. Mucoadhesive buccal patches of lornoxicam: II– in-vivo evaluation and clinical efficacy. Bulletin of Pharmaceutical Sciences Assiut University, 2011; 34(1): 21-30.
41. Winning L, Polyzois I, Nylund K, Kelly A, Claffey N. A placebo-controlled trial to evaluate an anesthetic gel when probing in patients with advanced periodontitis. J Periodontol. 2012 Dec;83(12):1492-8.
42. Angelopoulou MV, Vlachou V, Halazonetis DJ. Pharmacological management of pain during orthodontic treatment: a meta-analysis. Orthod Craniofac Res. 2012 May;15(2):71-83.
43. Nóbrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6.
44. Cavallari C, Fini A, Ospitali F. Mucoadhesive multiparticulate patch for the intrabuccal controlled delivery of lidocaine. Eur J Pharm Biopharm Off J Arbeitsgemeinschaft Pharm Verfahrenstechnik EV. 2013 Apr;83(3):405–14.
45. Hersh EV, Ciancio SG, Kuperstein AS, Stoopler ET, Moore PA, Boynes SG, et al. An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: efficacy, tolerability and compliance with label dose administration directions. J Am Dent Assoc 1939. 2013 May;144(5):517–26.
46. Sandhu SS, Sandhu J. A randomized clinical trial investigating pain associated with superelastic nickel–titanium and multistranded stainless steel archwires during the initial leveling and aligning phase of orthodontic treatment. J Orthod. 2013 Dec;40(4):276–85.
47. Eslamian L, Borzabadi-Farahani A, Edini HZ, Badiee MR, Lynch E, Mortazavi A. The analgesic effect of benzocaine mucoadhesive patches on orthodontic pain caused by elastomeric separators, a preliminary study. Acta Odontol Scand. 2013 Sep;71(5):1168–73.
48. Asiry MA, Albarakati SF, Al-Marwan MS, Al-Shammari RR. Perception of pain and discomfort from elastomeric separators in Saudi adolescents. Saudi Med J. 2014 May;35(5):504–7.
49. Sharma A, Suprabha BS, Shenoy R, Rao A. Efficacy of lignocaine in gel and spray form during buccal infiltration anesthesia in children: a randomized clinical trial. J Contemp Dent Pract. 2014 Nov 1;15(6):750–4.
50. Bhutkar KG. Formulation and evaluation of mucoadhesive herbal buccal patch of Psidium guava L. J Curr Pharma Res. 2014 Dec;5(1):1372-7.
51. Al-Samadani KH, Gazal G. Effectiveness of benzocaine in reducing deep cavity restoration and post-extraction stress in dental patients. Saudi Med J. 2015 Nov;36(11):1342–7.
52. Rajeswari SR, Gowda TM, Kumar TA, Thimmasetty J, Mehta DS. An appraisal of innovative meloxicam mucoadhesive films for periodontal postsurgical pain control: A double-blinded, randomized clinical trial of effectiveness. Contemp Clin Dent. 2015 Jul-Sep;6(3):299-304.
53. Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22.
54. Annigeri RG, Jadhav M, Juturu T. Clinical evaluation of transmucosal mucoadhesive meloxicam patch in dental pain reduction: A preliminary study. Indian J Pain. 2015 May-Aug;29(2):82-85
55. Chaushu L, Weinreb M, Beitlitum I, Moses O, Nemcovsky CE. Evaluation of a topical herbal patch for soft tissue wound healing: an animal study. J Clin Periodontol. 2015;42(3):288–93.
56. Eslamian L, Borzabadi-Farahani A, Gholami H. The effect of benzocaine and ketoprofen gels on pain during fixed orthodontic appliance treatment: a randomised, double-blind, crossover trial. Aust Orthod J. 2016 May;32(1):64–72.
57. Pipalia PR, Annegeri RG, Juturu T, Mehta R. Control of odontogenic pain by diclofenac and meloxicam mucoadhesive patches: A randomized, double-blinded, placebo-controlled, preliminary study. J Indian Acad Oral Med Radiol. 2016 Sep;28(3):229.
58. Hashemi M, Ramezani V, Seyedabadi M, Ranjbar AM, Jafari H, Honarvar M, et al. Formulation and Optimization of Oral Mucoadhesive Patches of Myrtus Communis by Box Behnken Design. Adv Pharm Bull. 2017 Sep;7(3):441–50.
59. Eslamian L, Akbarian Rad N, Rahbani Nobar B, Mortazavi SA. Effect of a 5% naproxen patch on reducing pain caused by separators prior to fixed orthodontic treatment. J Dent Anesth Pain Med. 2018 Jun;18(3):151–9.
60. Clitherow KH, Murdoch C, Spain SG, Handler AM, Colley HE, Stie MB, et al. Mucoadhesive Electrospun Patch Delivery of Lidocaine to the Oral Mucosa and Investigation of Spatial Distribution in a Tissue Using MALDI-Mass Spectrometry Imaging. Mol Pharm. 2019 Sep 3;16(9):3948–56.
61. Diwan V, Srinivasa TS, Ramreddy KY, Agrawal V, Nagdeve S, Parvez H. A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study. Indian J Dent Res. 2019 Jan-Feb;30(1):57-60.
62. Kaur H, Bansal N, Abraham R. A randomized, single-blind, placebo-controlled trial to evaluate the effectiveness of verbal behavior modification and acetaminophen on orthodontic pain. Angle Orthod. 2019 Jul;89(4):617–23.
63. Al-Melh MA, Nada A, Badr H, Andersson L. Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement. J Contemp Dent Pract. 2019 Nov 1;20(11):1286–92.
64. Tripathi T, Singh N, Rai P, Khanna N. Separation and pain perception of Elastomeric, Kesling and Kansal separators. Dent Press J Orthod. 2019 Apr;24(2):42.
65. Escalona-Rayo CF, Serrano-Castañeda P, López-Cervantes M, et al. Optimization of unidirectional mucoadhesive buccal patches based on chitosan and Pluronic® F-127 for metoprolol controlled release: in vitro and ex vivo evaluations. J Pharm Innov. 2020 Dec;15:556–568.
66. Anantharaj A, Sabu JM, Ramakrishna S, Jagdeesh RB, Praveen P, Shankarappa PR. A comparative evaluation of pain perception following topical application of benzocaine gel, clove-papaya based anesthetic gel and precooling of the injection site before intraoral injections in children. J Indian Soc Pedod Prev Dent. 2020 Apr-Jun;38(2):184-189.
67. Almallah MME, Hajeer MY, Almahdi WH, Burhan AS, Latifeh Y, Madkhaneh SK. Assessment of a single versus double application of low-level laser therapy in pain reduction following orthodontic elastomeric separation: A randomized controlled trial. Dent Med Probl. 2020 Jan-Mar;57(1):45-52.
68. Arabi M, Mortazavi SA, Jafariazar Z, Farhadnejad H, Alipour Harisa G, Fatahi Y. Fabrication and In-vitro Evaluation of Buccal Mucoadhesive Tablet of Meloxicam. Iran J Pharm Res. 2020 Summer;19(3):63-76.
69. Ridwan RD, Yuliati Y, Sidarningsih S, Sholihah FM, Aljunaid M, Lashari DM. A study of the mucoadhesive patches loaded with mangosteen peel extract in periodontitis. J Taibah Univ Med Sci. 2021 Aug 7;16(6):864–9.
70. Havale R, Rao DG, S P S, M Tuppadmath K, Tharay N, Mathew I, et al. Comparative evaluation of pain perception following topical application of clove oil, betel leaf extract, lignocaine gel, and ice prior to intraoral injection in children aged 6-10 years: a randomized control study. J Dent Anesth Pain Med. 2021 Aug;21(4):329–36.
71. Soheilifar S, Zandian M, Fathi H, Soheilifar S, Farhadian M, Soheilifar S. Effect of menthol on pain perception after placing brass wire separators: A split-mouth randomized controlled trial. Clin Investig Orthod. 2022 Jul 3;81(3):153–60.
72. Molania T, Malekzadeh Shafaroudi A, Saeedi M, Moosazadeh M, Valipour F, Rostamkalaei SS, et al. Evaluation of cinnamaldehyde mucoadhesive patches on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial. BMC Oral Health. 2022 Jun 14;22(1):235.
73. John NE, Erakkodan R, Sreelakshmi N. Efficacy of benzocaine and lidocaine bioadhesive patches in various minor oral surgical procedures in children - An evaluative study. Indian J Dent Res. 2023 Apr-Jun;34(2):145-149.
74. Thejasri K, Singaraju GS, Marya A, Priyanka JSY, Shaik S, Mandava P. Separation effect, pain perception during functional activity and gingival inflammation of elastomeric and Kansal separators-a split mouth study. Clin Oral Investig. 2023 Oct;27(10):6015–26.
75. Attar ES, Chaudhari VH, Deokar CG, Dyawanapelly S, Devarajan PV. Nano Drug Delivery Strategies for an Oral Bioenhanced Quercetin Formulation. Eur J Drug Metab Pharmacokinet. 2023 Sep;48(5):495-514.
76. Petluru H, Nirmala S, Nuvvula S. A comparative evaluation of peppermint oil and lignocaine spray as topical anesthetic agents prior to local anesthesia in children: a randomized clinical trial. J Dent Anesth Pain Med. 2024 Apr;24(2):119–28.
77. Park K. Park's Textbook of Preventive and Social Medicine. 21st ed. Jabalpur: M/S Banarsidas Bhanot; 2018.
78. Liljequist D, Elfving B, Skavberg Roaldsen K. Intraclass correlation – A discussion and demonstration of basic features. PLoS ONE. 2019 Jul 22;14(7):e0219854.
79. Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofac Orthop Off Publ Am Assoc Orthod Its Const Soc Am Board Orthod. 1989 Jul;96(1):47–53.
80. Jahromi B, Pirvulescu I, Candido KD, Knezevic NN. Herbal Medicine for Pain Management: Efficacy and Drug Interactions. Pharmaceutics. 2021 Feb 11;13(2):251.
81. Liu C, Liu DQ, Tian YK, Mei W, Tian XB, Xu AJ, Zhou YQ. The Emerging Role of Quercetin in the Treatment of Chronic Pain. Curr Neuropharmacol. 2022 Nov 15;20(12):2346-2353.
82. Pahade A, Bajaj P, Shirbhate U, John HA. Recent Modalities in Pain Control and Local Anesthesia in Dentistry: A Narrative Review. Cureus. 2023 Nov 7;15(11):e48428.
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