Comparative Efficacy of Oxitard Capsules and Immusante Tablets in Early Stages of Oral Submucous Fibrosis - A Randomized Controlled Trial
DOI:
https://doi.org/10.31584/jhsmr.20241064Keywords:
antioxidants, ayurvedic, dentistry, immunomodulators, oral submucous fibrosisAbstract
Objective: Oral submucous fibrosis (OSMF) is manifested by symptoms such as palpable fibrotic bands, ulceration, presence of stiffness in the mouth and lip, xerostomia, pigmentation in the oral mucosal layer, and burning sensation and drying of the mouth. It poses a challenge for researchers as there is no viable therapy for this gradually debilitating disorder with a high malignancy potential. Ayurveda is a traditional medicinal practice of the past and present times which can be useful in providing a viable cure. Thus, the current study was designed to assess and compare the effect of Oxitard capsule and Immusante tablet on the clinical and subjective symptoms of OSMF.
Material and Methods: The study included 36 patients with clinically diagnosed OSMF who were split evenly into two groups: Group A, the Oxitard group, and Group B, the Immusante group. For three months, Group A received two Oxitard capsules twice daily, while Group B received two Immusante tablets twice daily. At regular intervals, the clinical parameters were evaluated, and the data were analysed using repeated measures ANOVA and the Bonferroni post hoc test. P-value≤0.05 was regarded as statistically significant.
Results: On assessment of mouth opening, tongue protrusion, cheek flexibility and subjective symptoms there was significant improvement reported in both groups. In group comparison, the Oxitard and Immusante groups showed a significant difference in cheek flexibility at 3 months. There were no significant differences in subjective symptoms in either of the groups pre- and post-treatment.
Conclusion: Efficacy of both the drugs were equall was found to be similar when used as an adjunct to tobacco cessation counselling in the management of early stages of oral submucous fibrosis when used as an adjunct to behavioral management.
References
Rawson K, Prasad RK, Nair AK, Josephine J. Oral submucous fibrosis–The Indian scenario: review and report of three treated cases. J Ind Academy Oral Med Radiol 2017;29:354-7.
Dionne KR, Warnakulasuriya S, Zain RB, Cheong SC. Potentially malignant disorders of the oral cavity: current practice and future directions in the clinic and laboratory. Int J Cancer 2015;136:503–15.
Nigam NK, Aravinda K, Dhillon M, Gupta S, Reddy S, Srinivas Raju M. Prevalence of oral submucous fibrosis among habitual gutkha and areca nut chewers in Moradabad district. J Oral Biol Craniofac Res 2014;4:8–13.
Chang MC, Chiang CP, Lin CL, Lee JJ, Hahn LJ, Jeng JH. Cell-mediated immunity and head and neck cancer: with special emphasis on betel quid chewing habit. Oral Oncol 2005;41:757–75.
Shrikrishna BH, Jyothi AC. Prevalence of areca nut eating habits and its association with oral submucous fibrosis in preuniversity college going adolescents of Raichur in Karnataka, India: a prospective cross-sectional survey. Int J Head Neck Surg 2012;7:197-203.
Das RK, Anura A, Pal M, Bag S, Majumdar S, Barui A, et al. Epithelio-mesenchymal transitional attributes in oral submucous fibrosis. Exp Mol Pathology 2013;95:259–69.
More CB, Das S, Patel H, Adalja C, Kamatchi V, Venkatesh R. Proposed clinical classification for oral submucous fibrosis. Oral Oncology 2012;48:200–2.
More CB, Gupta S, Joshi J, Varma SN. Classification system for oral submucous fibrosis. J Ind Academy Oral Med Radiol 2012;24:24.
Passi D, Bhanot P, Kacker D, Chahal D, Atri M, Panwar Y. Oral submucous fibrosis: Newer proposed classification with critical updates in pathogenesis and management strategies. Natl J Maxillofac Surg 2017;8:89–94.
Patel KR, Rajagopala M, Vaghela DB, Shah A. A pilot study on Ayurvedic management of oral submucous fibrosis. Ayu 2015;36:34–40.
Jacqui W. Herbal products are often contaminated, study finds. BMJ 2013;347:f6138.
Patil SR, Maragathavalli G, Ramesh D, Al-Zoubi IA, Rajendran R, Alam MK. The role of antioxidants and natural agents in the management of oral submucous fibrosis: a systematic review. Int Med J 2020;27:199–203.
Dubey P, Mittal N. Review on oral submucous fibrosis: new theoretical approaches with etiopathogenesis and ayurvedic treatments. Int J Res Analytical Rev 2020;7:15.
Patil S, Halgatti V, Maheshwari S, Santosh BS. Comparative study of the efficacy of herbal antioxdants oxitard and aloe vera in the treatment of oral submucous fibrosis. J Clin Exp Dent 2014;6:e265–70.
Gupta PC, Warnakulasuriya S. Global epidemiology of areca nut usage. Addiction Bio 2002;7:77–83.
Prabhu RV, Prabhu V, Chatra L, Shenai P, Suvarna N, Dandekeri S. Areca nut and its role in oral submucous fibrosis. J Clin Exp Dent 2014;6:e569–75.
Khandelwal A, Khandelwal V, Saha MK, Khandelwal S, Prasad S, Saha SG. Prevalence of areca nut chewing in the middle school-going children of Indore, India. Contemp Clin Dent 2012;3:155–7.
Prajapati D, Nayak R, Nayak U, Shah P. Areca nut chewing habit in preschoolers: two rare case reports and literature review. Int J Dent Health Con 2015;1:23–7.
Parmar S, Siwach AK, Kumar A. Fifty years research output in oral submucous fibrosis, a bibliometric analysis of publications from 1967 to 2016. DESIDOC J Lib Info Tech 2020;40:122–30.
Jiang X, Hu J. Drug treatment of oral submucous fibrosis: a review of the literature. J Oral Maxillofac Surg 2009;67:1510–5.
Sanjay CJ, Shastry SP, Patil K, Doggalli N, Kumar N, Sharma S. Herbal therapy in oral submucous fibrosis: a short review. Ind J Forensic Med Toxicol 2021;15:509-13.
Patil S, Santosh BS, Maheshwari S, Deoghare A, Chhugani S, Rajesh PR. Efficacy of oxitard capsules in the treatment of oral submucous fibrosis. J Cancer Res Therap 2015;11:291-4.
Patil S, Yadav N, Al-Zoubi I, Maragathavalli G, Sghaireen M, Gudipaneni R, et al. Comparative study of the efficacy of newer antioxidants lycopene and oxitard in the treatment of oral submucous fibrosis. Pesqui Bras Odontopediatria Clín Integr 2018;18:1–7.
Singh BP, Mittal N, Sharma V. Palani. Evaluation of role of oxitard capsules in the treatment of oral submucous fibrosis. Antiseptic 2009;106:503-7.
Gopinath D, Hui LM, Veettil SK, Balakrishnan Nair A, Maharajan MK. Comparative efficacy of interventions for the management of oral submucous fibrosis: a systematic review and network meta-analysis. J Personalized Med 2022;12:1272.
Rajendran R, Rani V, Shaikh S. Pentoxifylline therapy: a new adjunct in the treatment of oral submucous fibrosis. Ind J Dent Res 2006;17:190.
More CB, Jatti Patil D, Rao NR. Medicinal management of oral submucous fibrosis in the past decade-a systematic review. J Oral Biol Craniofac Res 2020;10:552–68.
Butera A, Pascadopoli M, Pellegrini M, Gallo S, Zampetti P, Scribante A. Oral microbiota in patients with peri-implant disease: a narrative review. Applied Sciences 2022;12:3250.
Vale GC, Mayer MPA. Effect of probiotic Lactobacillus rhamnosus by-products on gingival epithelial cells challenged with Porphyromonas gingivalis. Arch Oral Biol 2021;128:105174.
Butera A, Pascadopoli M, Pellegrini M, Gallo S, Zampetti P, Cuggia G, et al. Domiciliary use of chlorhexidine vs. postbiotic gels in patients with peri-implant mucositis: a split-mouth randomized clinical trial. Appl Sci 2022;12:2800.
Khaaviya N, Vezhavendhan N, Sivaramakrishnan M. Pentoxifylline therapy in the management of oral submucous fibrosis: a review. J Scientific Dent 2018;8:19–21.
Fuchs J. The amount of liquid patients use to take tablets or capsules. Pharm Pract (Granada) 2009;7:170–4.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
