Oral medicine| Volume 122, ISSUE 6, P713-718, December 2016

A randomized control trial measuring the effectiveness of a mouth-exercising device for mucosal burning in oral submucous fibrosis

Published:August 06, 2016DOI:


      To evaluate effect of ice-cream stick exercise regimen with or without a mouth-exercising device (MED) on mucosal burning sensation in oral submucous fibrosis.

      Study Design

      In total, 282 patients with oral submucous fibrosis were treated with topical corticosteroid and oral antioxidant and the ice-cream stick exercise regimen. Patients in subgroups A1, A2, and A3 were additionally given a new MED. Patients in subgroups A1 and B1 patients with interincisal distance (IID) of 20 to 35 mm were managed without any additional therapy; patients in subgroups A2 and B2 with IID of 20 to 35 mm were additionally managed with intralesional injections; and those in subgroups A3 and B3 with IID less than 20 mm were managed surgically. Subjective evaluation of decrease in the oral mucosal burning was measured on a visual analogue scale (VAS). Analysis of variance and Tukey's multiple post hoc analysis were carried out to present the results.


      Patients using the MED, that is, subgroups A1, A2, and A3, showed reduction in burning sensation in the range of 64.8% to 71.1% and 27.8% to 30.9%, whereas in subgroups B1, B2, and B3, reduction in burning sensation ranged from 64.7% to 69.9% and from 29.3% to 38.6% after 6 months. The wo-way analysis of variance indicated statistically significant results in changes in initial VAS scores to 6-monthly VAS scores between MED users and non-MED users.


      The MED helps to enhance the rate of reduction of mucosal burning sensation, in addition to the conventional ice-cream stick regimen, as an adjunct to local and surgical treatment.
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        • Pindborg J.J.
        • Sirasat S.M.
        Oral submucous fibrosis.
        Oral Surg Oral Med Oral Pathol. 1966; 22: 746-779
        • Aziz S.R.
        Coming to America: betel nut and oral submucous fibrosis.
        J Am Dent Assoc. 2010; 141: 423-428
        • Farrand P.
        • Rowe R.M.
        • Johnston A.
        • Murdoch H.
        Prevalence, age of onset and demographic relationships of different areca nut habits amongst children in Tower Hamlets, London.
        Br Dent J. 2001; 190: 150-154
        • van Wyk C.W.
        • Seedat H.A.
        • Phillips V.M.
        Collagen in submucous fibrosis: an electron microscopic study.
        J Oral Pathol Med. 1990; 19: 182-187
        • Sinor P.N.
        • Gupta P.C.
        • Murti P.R.
        A case control study of oral submucous fibrosis with special reference to the etiologic role of areca nut.
        J Oral Pathol Med. 1990; 19: 94-98
        • Angadi P.V.
        • Rao S.
        Management of oral submucous fibrosis: an overview.
        Oral Maxillofac Surg. 2010; 14: 133-142
        • Lai D.R.
        • Chen H.R.
        • Lin L.M.
        • Huang Y.L.
        • Tsai C.C.
        Clinical evaluation of different treatment methods for oral submucous fibrosis. A 10-year experience with 150 cases.
        J Oral Pathol Med. 1995; 24: 402-406
        • Cox S.
        • Zoellner H.
        Physiotherapeutic treatment improves oral opening in oral submucous fibrosis.
        J Oral Pathol Med. 2009; 38: 220-226
        • Le P.V.
        • Gornitsky M.
        • Domanowski G.
        Oral stent as treatment adjunct for oral submucous fibrosis.
        Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996; 81: 148-150
        • Heller F.
        • Wei F.C.
        • Chang Y.M.
        • et al.
        A non-tooth-borne mouth-opening device for postoperative rehabilitation after surgical release of trismus.
        Plast Reconstr Surg. 2005; 116: 1856-1859
        • Patil P.G.
        • Patil S.P.
        Novel mouth-exercising device for oral submucous fibrosis.
        J Prosthodont. 2012; 21: 556-560
        • Patil P.
        • Hazarey V.
        • Chaudhari R.
        • Nimbalkar-Patil S.
        Clinical efficacy of a mouth-exercising device adjunct to local ointment intra-lesional injections and surgical treatment for oral submucous fibrosis: a randomized controlled trial.
        Asian Pac J Cancer Prev. 2016; 17: 1255-1259
        • Sarode S.G.
        • Sarode G.S.
        Burning sensation in oral submucous fibrosis and its possible association with mucin secreted by affected minor salivary glands.
        Oral Oncol. 2013; 49: e16-e17
        • Sharma R.
        • Thapliyal G.K.
        • Sinha R.
        • Menon P.S.
        Use of buccal fat pad for treatment of oral submucous fibrosis.
        J Oral Maxillofac Surg. 2012; 70: 228-232
        • Gupte S.
        • Sorathia R.
        • Shetye A.
        Autogenous buccal fat pad in the treatment of oral submucous fibrosis: a case report and review of literature.
        Int J Sci Study. 2014; 1: 48-51
        • Arora P.K.
        • Deshpande M.
        Effect of ultrasound and jaw opening exercises in cases of oral submucous fibrosis.
        Indian J Physiother Occup Ther. 2010; 4: 45-47
        • Bierman W.
        Ultrasound in the treatment of scars.
        Arch Phys Med Rehabil. 1954; 35: 209-214
        • Hashibe M.
        • Sankarnarayanan R.
        • Thomas G.
        • et al.
        Body mass index, tobacco chewing, alcohol drinking and risk of oral sub mucous fibrosis in Kerala, India.
        Cancer Causes Control. 2002; 13: 55-64
        • Huang I.Y.
        • Wu C.F.
        • Shen Y.S.
        • et al.
        Importance of patient's cooperation in surgical treatment of oral submucous fibrosis.
        J Oral Maxillofac Surg. 2008; 66: 699-703