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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 34  |  Issue : 4  |  Page : 405-408

Effectiveness of a mouth-exercising device in adjunct to topical steroid and antioxidants in OSMF—A clinical study


1 Department of Oral Medicine and Radiology, Al-Badar Rural Dental College and Hospital, Kalaburagi, Karnataka, India
2 Department of Oral Medicine and Radiology, Navodaya Dental College, Raichur, Karnataka, India

Date of Submission27-Aug-2022
Date of Decision22-Nov-2022
Date of Acceptance23-Nov-2022
Date of Web Publication09-Dec-2022

Correspondence Address:
Sadia Shahana
Department of Oral Medicine and Radiology, Al-Badar Rural Dental College and Hospital, Kalaburagi, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jiaomr.jiaomr_237_22z

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   Abstract 


Objective: To evaluate the effectiveness of a mouth-exercising device (MED) on mucosal burning sensation and interincisal distance in adjunct to topical steroids and antioxidants in oral submucous fibrosis (OSMF) patients. Material and Methods: The study consisted of a total sample size of 60 subjects diagnosed with OSMF with no other systemic diseases. Group I includes 30 patients on topical application of triamcinolone 0.1% and oral antioxidant capsule along with receiving MED. Group II includes 30 patients on topical application of triamcinolone 0.1% and oral antioxidant capsule without receiving MED. Evaluation for mucosal burning sensation (BS) and interincisal distance (IID) was determined by VAS & digital Vernier caliper. Results: Group I patients using MED showed a statistically significant reduction in burning sensation and increasing interincisal distance compared to group II after six months. Conclusion: The MED helps enhance the rate of reduction of mucosal burning sensation and it is effective in increasing interincisal distance compared to the non-mouth-exercising device in OSMF.

Keywords: Antioxidants, interincisal distance, mouth-exercising device, mucosal burning sensation, oral submucous fibrosis
Key Message: The MED, when used along with topical triamcinolone 0.1% and oral antioxidants, aids in increasing interincisal distance in OSMF patients.


How to cite this article:
Shahbaz S, Shahana S, Katti G, Ara SA, Tanveer K. Effectiveness of a mouth-exercising device in adjunct to topical steroid and antioxidants in OSMF—A clinical study. J Indian Acad Oral Med Radiol 2022;34:405-8

How to cite this URL:
Shahbaz S, Shahana S, Katti G, Ara SA, Tanveer K. Effectiveness of a mouth-exercising device in adjunct to topical steroid and antioxidants in OSMF—A clinical study. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2023 Feb 3];34:405-8. Available from: http://www.jiaomr.in/text.asp?2022/34/4/405/363028




   Introduction Top


Oral submucous fibrosis (OSMF) is a potentially malignant condition that is simple to diagnose and difficult to manage.[1] The main etiology is chewing of betel quid. The treatment focuses on the cessation of the betel nut chewing habit and stalling the progression of fibrosis.[2] The fibrosis of muscle causes stiffness of oral mucosa with increasing difficulty in mouth opening and tongue protrusion.[3] OSMF was seen at a younger age and shows male predominance.[4] The incidence of OSMF is very high, and effective medical and surgical treatment is yet lacking. Therefore, early diagnosis and intervention are recommended.[5] Corticosteroids and antioxidants are beneficial and are used in cancer prevention and cure.[6],[7] MED causes local squeezing and stretching of the mucosa, increasing mucosal tissues' elasticity and mouth opening.[2]

In light of the above literature, treating OSMF with topical corticosteroids, antioxidants, and physiotherapy with MED was not extensively studied. Hence, the present study aims to evaluate the effectiveness of MED on mucosal burning sensation and IID in adjunct to topical steroids and antioxidants in OSMF patients.


   Subjects and Methods Top


Sixty OSMF-diagnosed patients were selected based on predetermined clinical criteria between 18 and 40 yrs. The study was approved by the institutional ethical committee IEC/2019-20/12; procedures followed the ethical standards of the World Medical Association Declaration of Helsinki, 64th WMA General Assembly, Brazil, 2013. Diagnosis of OSMF was based on clinical classification by Tinky Bose and Anita Balan[8] set by clinical criteria. The patients with IID between 15 and 30 mm, who volunteered to participate in the study and were willing to return for the follow-ups, were selected after obtaining informed consent. The patients with IID less than 15 mm and more than 30 mm, a history of systemic diseases, other mucosal lesions, malignant lesions, TMJ problems, and pericoronitis of the lower third molars were excluded. Every registered patient in this study was treated with 'the intention to treat principle.

All patients were randomized following a simple randomization procedure into two groups, group I (MED) and group II (non-MED), if they satisfied the inclusion criteria and consented to the study. All the patients were treated with topical application of triamcinolone 0.1% (to be applied with an applicator swab to affected mucosa two times/day), oral antioxidant capsule (alpha lipoic acid 100 mg once a day), and with or without MED.

The technique of fabrication of MED was done by the method given by Patil and Patil.[9]

Method of use of MED

The patients were instructed that the MED can be used by orally positioning smaller plates intraorally and bigger plate extra. The cheek mucosa was squeezed repeatedly by changing the position of MED all over the affected region. The patient was encouraged to exercise for 20 min (10 min on each side) with the help of MED three times daily unless discomfort or tissue injury occurred.[9] To ensure the patients are using MED in the prescribed manner, routine follow-up was done at regular intervals once a month. All the patients reported at the follow-up visits without any compliance.

The change in the mucosal BS was calculated by the difference in the measurements of VAS scores at the baseline and the six monthly follow-ups. The change in the IID was measured at the baseline and 6-month follow-up using digital Vernier caliper. The data obtained was statistically analyzed by IBM SPSS 20.0 version software.


   Results Top


The study group comprised 60 subjects, with the mean age of all cases being 28.84 ± 8.73. There was no statistical S difference in mean age between group I and group II. There was no statistically significant difference in mean BS in OSMF between group I and group II (P > 0.05) at baseline. At six monthly follow-ups, the mean BS in group I patients performing additional physiotherapy with MED showed a more reduced rate than group II (non-MED) [Table 1]. While on the comparison, there was no statistically significant difference in mean IID in OSMF between group I and group II (P > 0.05) at baseline. At the 6-month follow-up, the mean IID was significantly higher in group I (MED) compared to group II (non-MED) [Table 2]. On comparison of mean BS in OSMF at baseline and 6-month follow-up (P < 0.001), there was a statistical VHS (very highly significant) difference in group I. There was also a significant difference in mean BS in OSMF between baseline and 6-month follow-up (P < 0.001) in group II [Table 3]. On comparison of mean IID in OSMF at baseline and 6-month follow-up (P < 0.001), there was a statistical VHS difference in group I. There was also a statistically significant difference in mean IID in OSMF between baseline and 6-month follow-up (P < 0.001) in group II [Table 4].
Table 1: Comparison of mucosal BS in OSMF cases, with topical triamcinolone 0.1%, oral antioxidants with and without MED

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Table 2: Comparison of IID in OSMF cases, with topical triamcinolone 0.1%, oral antioxidants with and without MED

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Table 3: Comparison of mucosal BS in OSMF cases, with topical triamcinolone 0.1%, oral antioxidants at baseline, and 6-month follow-up with and without MED

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Table 4: Comparison of IID in OSMF cases, with topical triamcinolone 0.1%, oral antioxidants at baseline, and 6-month follow-up with and without MED

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   Discussion Top


OSMF is a chronic fibrotic condition characterized by stiffness of oral mucosa due to excessive deposition and cross-linking of collagen.[2] The hallmark of the disease is progressive juxta-epithelial fibrosis of oral soft tissues resulting in restricted mouth opening and burning sensation.[2] One of the most etiological risk factors is chewing betel quid/areca nut. Hence, the primary therapy should be a cessation of the habit.

OSMF is exhibited clinically as a blanched appearance of the mucosa and palpation of fibrous bands traversing the oral mucosa causing rigidity and restricted movement.[10] Fibrosis and hyalinization around minor salivary glands due to the OSMF leads to a reduction in the secretion of saliva.[2] This results in a reduction of salivary mucous gel [SMG] formation in local areas. This SMG barrier loss may hamper the “protective diffusion membrane” function of SMG, causing minimal protection against irritation from food substances, e.g., spicy and hot food. This mechanism could be mainly responsible for the burning sensation of the oral cavity.[2]

The patient's cooperation is the primary concern for the successful physiotherapy treatment of OSMF. Hence, this study evaluated the patients' perception of positive or negative changes in burning sensation on the VAS.

In our study, a comparison of initial and six monthly VAS scores indicated statistical VHS reduction of the BS. However, the patients performing additional physiotherapy with the MED showed more rate of reduction than non-MED users. This suggests that using MED enhances the rate of reduction in mucosal BS. However, physiotherapy's exact mode of action in reducing the burning sensation in OSMF has yet to be explained and studied extensively in the literature.

The physiotherapeutic effect causes the loosening of adherent fibrous tissue due to the separation of collagen fibers from each other and softening of the cement substance, thus leading to increased elasticity. Due to the massage effect, the MED causes the separation of the collagen fibers. It may increase the subcutaneous matrix areas, improving mucosal elasticity and blood circulation,[2],[9] which may play an adjuvant role in reducing the burning sensation. Further, MED causes local squeezing and stretching of the mucosa, which increases the elasticity of the mucosal tissues, leading to an increase in mouth opening.[3]

In our study, males predominance over females was seen because they used gutkha and similar products more because of easy accessibility to use areca nut and its products frequently than females in our region.

In the present study, the mean value of BS between the initial and 6-month follow-up in the MED group & non-MED group showed a statistically significant difference in mean BS in OSMF, which is by the study done by Patil et al.,[2] which concluded that patients performing additional physiotherapy with the MED showed more rate of reduction than non-MED users, which may be because the salivary substitute containing mucin would help in the formation of SMG layer over the surface of oral epithelium in OSMF. This will restore the “protective diffusion membrane function,” thereby reducing the BS of the oral cavity.[11]

Triamcinolone is said to reduce the burning sensation in the oral cavity; this is similar to a study done by Devgan et al.[12] which showed a statistically significant difference in burning sensation, which is similar to the study done. However, Naik et al.[5] concluded that triamcinolone had no effect in reducing the BS in OSMF patients, which contrasts with our study.

In the present study, the mean value of IID between the initial and six monthly follow-ups in group I and group II showed statistical VHS difference, similar studies with an exercising device done by Patil et al.,[2] Nallan et al.,[13] Reddy et al.,[14] Cox and Zoellner,[15] Hassan and Bhateja,[16] and Kamstra et al.[10] also showed increased mouth opening in MED group. Thus, physiotherapy can be used as an adjunct therapy to improve mouth opening in patients with OSMF.


   Conclusion Top


OSMF is well-recognized, potentially premalignant condition with a considerable malignancy transformation rate. Early diagnosis and prompt treatment offer the best hope of improving the prognosis in patients with OSMF. The MED causes the separation of the submucous fibers, which may increase tissue flexibility. In addition, separating the fibers may increase the subcutaneous matrix areas for improved circulation, resulting in local tissue remodel to increase the elasticity of mucosa, which aids in improving mouth opening. To conclude, the MED, when used along with topical triamcinolone 0.1% and oral antioxidants, aids in increasing inter-incisal distance in OSMF patients.

Limitations

Although our sample size was less, this may lay foundation for further extensive research in the treatment of OSMF patients.

Future perspectives

The use of MED along with corticosteroids and antioxidants may aid in improving the prognosis in patients with OSMF. Further studies with a larger sample size are suggested to enhance the knowledge in this particular arena.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Sharma R, Raj SS, Mishra G, Reddy YG, Shenava S, Narang P. Prevalence of oral submucous fibrosis in patients visiting dental college in rural area of Jaipur, Rajasthan. J Indian Acad Oral Radiol 2012;24:1–4.  Back to cited text no. 1
    
2.
Patil PG, Hazarey V, Chaudhari R, Nimbalkar-Patil S. A randomized control trial measures the effectiveness of a mouth-exercising device for mucosal burning in oral submucous fibrosis. Oral Surg Oral Med Oral Pathol Oral Radiol 2016;122:713–8.  Back to cited text no. 2
    
3.
Agarwal N, Singh D, Sinha A, Srivastava S, Prasad RK, Singh G. Evaluation of the efficacy of turmeric in management of oral submucous fibrosis. J Indian Acad Oral Med Radiol 2014;26:260–3.  Back to cited text no. 3
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Noor-ul-Wahab SA, Khan M, Khan S, Mehdi H, Sawani A. Frequency and clinical presentation of oral submucous fibrosis. Pak J Med Dent 2014;3:48–53.  Back to cited text no. 4
    
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Memon A, Shahid H, Shafique S. Oral submucous fibrosis; Comparison of efficacy between clobetasol and triamcinolone application in oral submucous fibrosis patients with a burning sensation. Prof Med J 2018;25:1005–12.  Back to cited text no. 5
    
6.
Hazarey VK, Sakrikar AR, Ganvir SM. Efficacy of curcumin in treating oral submucous fibrosis: A randomized control trial. J Oral Pathol Med 2015;19:145–52.  Back to cited text no. 6
    
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Kumar BV. Role of antioxidants in treating oral submucous fibrosis: A clinical and histopathological study. J Indian Acad Oral Med Radiol 2009;21:179–83.  Back to cited text no. 7
    
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Tinky B, Anita B. Oral submucous fibrosis- A changing scenario. J Indian Acad Oral Med Radiol 2007;19:334-40.  Back to cited text no. 8
    
9.
Patil PG, Patil SP. Novel mouth-exercising device for oral submucous fibrosis. J Prosthodont 2012;21:556–60.  Back to cited text no. 9
    
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Kamstra JI, Roodenburg JL, Beurskens CH, Reintsema H, Dijkstra PU. TheraBite exercises to treat trismus secondary to head and neck cancer. Support Care Cancer 2013;21:951–7.  Back to cited text no. 10
    
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Sarode SG, Sarode GS. Burning sensation in oral submucous fibrosis and its possible association with mucin secreted by affected minor salivary glands. Oral Oncol 2013;49:e16–7.  Back to cited text no. 11
    
12.
Devgan K, Mistry P, Nagpal T. A prospective study of evaluation of methods to decrease the morbidity in oral submucous fibrosis. International J Adv Sci Res 2015;1:28–32.  Back to cited text no. 12
    
13.
Nallan CSK, Prasad CMSK, Danam RP, Nithika M, Suvarna C, Nancypriyanka J, et al. A new intraoral appliance for trismus in oral submucous fibrosis. Case Rep Dent 2018;2018:1039391. doi: 10.1155/2018/1039391.  Back to cited text no. 13
    
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Ramachandra Reddy GV, Shinde CV, Khare P. Novel physiotherapy appliance in managing oral submucous fibrosis. J Indian Acad Oral Med Radiol 2021;33:91–4.  Back to cited text no. 14
    
15.
Cox S, Zoellner H. Physiotherapeutic treatment improves oral opening in oral submucous fibrosis. J Oral Pathol Med 2009;38:220–6.  Back to cited text no. 15
    
16.
Hassan SA, Bhateja S. Role of physiotherapy in oral submucous fibrosis. J Soc Indian Physiother 2020;4:1–2.  Back to cited text no. 16
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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