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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 34  |  Issue : 1  |  Page : 27-32

Therapeutic assessment of intralesional corticosteroids and ultrasound therapy in management of oral submucous fibrosis: A comparative study


Department of Oral Medicine and Radiology, Govt. Dental College and Hospital, Ahmedabad, Gujarat, India

Date of Submission19-May-2021
Date of Decision27-Aug-2021
Date of Acceptance11-Nov-2021
Date of Web Publication25-Mar-2022

Correspondence Address:
Dr. Priyanka R Parmar
Department of Oral Medicine and Radiology, Govt. Dental College and Hospital, Ahmedabad, Gujarat - 380 006
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-5049.340729

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   Abstract 


Background: Oral submucous fibrosis (OSMF) is a premalignant condition with a chronic, debilitating, and resistant nature. Various treatment modalities have been proposed for this condition including steroid injections and surgical interventions. In literature, there are very few studies signifying the role of therapeutic ultrasound in OSMF and this still remains a hidden field which needs to be explored further. Aims and Objectives: To evaluate and compare the clinical efficacy of ultrasound therapy with and without physical exercise with intralesional injection (I/L) of 2 ml dexamethasone (4 mg/ml) + hyaluronidase 1500 IU with physical exercise in patients with OSMF. Materials and Method: A total of 30 patients with OSMF were selected irrespective of age and gender and were allocated into groups A, B and C randomly. Group A: 10 patients treated with I/L injection of dexamethasone and hyaluronidase with physical exercise. Group B: 10 patients treated with therapeutic ultrasound and soft tissue mobilization with physical exercise. Group C: 10 patients treated with therapeutic ultrasound and soft tissue mobilization without physical exercise. All the patients were evaluated weekly for 1 month and findings were compared with those at the beginning of treatment. Result: Ultrasound in combination with exercises leads to more improvement in mouth opening compared to ultrasound alone. Improvement in mouth opening of ultrasound with exercise was almost similar to intralesional injection of steroids. Conclusion: Ultrasound therapy interventions definitely show a significant improvement in the patient's condition with no reported side effects; hence it should be included in the treatment protocol for patients with OSMF.

Keywords: Intralesional injection, OSMF, ultrasound therapy


How to cite this article:
Parikh SJ, Parmar PR, Shah JS. Therapeutic assessment of intralesional corticosteroids and ultrasound therapy in management of oral submucous fibrosis: A comparative study. J Indian Acad Oral Med Radiol 2022;34:27-32

How to cite this URL:
Parikh SJ, Parmar PR, Shah JS. Therapeutic assessment of intralesional corticosteroids and ultrasound therapy in management of oral submucous fibrosis: A comparative study. J Indian Acad Oral Med Radiol [serial online] 2022 [cited 2022 May 27];34:27-32. Available from: https://www.jiaomr.in/text.asp?2022/34/1/27/340729




   Introduction Top


Oral submucous fibrosis (OSMF) is an insidious chronic disease affecting any part of the oral cavity and sometimes the pharynx. It is associated with juxtaepithelial inflammatory reaction followed by fibro-elastic changes in the lamina propria layer, along with epithelial atrophy which leads to rigidity of oral mucosa proceeding to trismus and difficulty in mouth opening.[1] OSMF is a debilitating but preventable oral disease with mucosal rigidity causing discomfort, burning and limitation of opening of the mouth.[2],[3] In India, the prevalence has increased from 0.03% to 6.42% over the past four decades; it occurs at any age but is most commonly seen in adolescents and adults especially between 16 and 35 years.[2],[4]

OSMF still remains enigmatically as the multifactorial model for pathogenesis: consumption of chilies, areca nut, iron and nutritional deficiencies, tobacco, lime, genetic abnormalities, altered salivary constituents, herpes simplex virus, human papilloma virus, and autoimmunity has been postulated to have their direct and indirect effects in OSMF.[5] The condition carries a high relative risk for malignant transformation (7.6%) even after the control of habit and the pre-cancerous nature of OSMF was reported by Paymaster.[3],[6]

The earliest clinical sign of OSMF is blanching of the oral mucosa followed by the appearance of fibrous bands in affected areas (Pindborg et al., 1980).[6] Haider SM et al.[7] clinically graded OSMF into stage I: faucial bands only; stage II: faucial bands and buccal bands; and stage III: facial, buccal and labial bands. They also functionally graded OSMF into stage A: mouth opening ≥20 mm; stage B: mouth opening 10–19 mm and stage C: mouth opening ≤10 mm.

Owing to its multifactorial etiology and pathogenesis, various modalities have been tried over the years, but no single modality has provided complete relief from symptoms of OSMF.[5] Ultrasonic waves penetrate the skin to cause vibrations in tendons and soft tissues, providing gentle deep tissue heating that decreases pain and inflammation to speed healing in OSMF patients.[8]

Ultrasound has been used extensively in physical medicine with considerable success. During ultrasound therapy cell membrane permeability is increased. This increased permeability improves gas exchange and promotes healing. It also decreases inflammation, increases vasodilatation and waste removal as well as accelerates lymph flow and stimulates metabolism. The objectives of ultrasound treatment are to accelerate healing, increase the extensibility of collagen fibers, and provide pain relief.[6] Kneading is an effective form of massage therapy in improving the elasticity of fibrous tissues, mobilizing scar tissues, and improving their extensibility. These all are the requirements of any therapy used for the treatment of OSMF.[5] In literature, there are very few studies signifying the role of therapeutic ultrasound in OSMF and this still remains a hidden field and thus needs to be explored further.

This study was undertaken to evaluate and compare the clinical efficacy of ultrasound therapy with and without physical exercise with intralesional injection of 2 ml dexamethasone (4 mg/ml) + hyaluronidase 1500 IU in patients with OSMF.


   Material and Methods Top


This study was conducted on 30 patients, clinically diagnosed with OSMF irrespective of age and sex in the Department of Oral Medicine and Radiology. Subjects in the study and procedures followed were in accordance with the ethical standards of Helsinki Declaration (2013) and the clinical protocol for the study was approved by the Institutional Ethics Committee (IEC GDCH/OMR.1/2021; Dated 24/03/2021).

Sample size estimation

Sample size (n = 30) estimation was done as per the formula below:

n (sample size) = [Z2 S2]/d2

S is Standard deviation of sample mean. S=11.60, Za (Critical value and a standard value for the corresponding level of confidence) = 1.96 i.e., 95% of C.I.

Selection criteria

Inclusion criteria

Patients clinically diagnosed with moderate and severe stage of OSMF irrespective of age and sex were included in study [Figure 1].
Figure 1: (a) Photograph showing blanching of buccal mucosa (moderate stage OSMF) (b and c) Restricted mouth opening in moderate and severe stage of OSMF patients

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Exclusion criteria

  • Patients not willing to participate in study;
  • OSMF patients with acute infection or associated with other lesions like leukoplakia, stomatitis nicotina, carcinoma, etc;
  • Patients with reduced mouth opening due to trauma, radiation, surgery, developmental disorders, TMDs or any other disease that mimics OSMF such as systemic sclerosis, tetany (screened by medical history/questionnaire), etc;
  • Patients with early stage of OSMF;
  • Patients previously treated with intralesional injection and/or ultrasound therapy for OSMF; and
  • Patients with any systemic disease where steroid administration was contraindicated.


Methodology

Written informed consent was obtained from all the patients before enrolling them in the study. Based on the inclusion and exclusion criteria, patients were included in the study and were explained the need and design of the study. Selected patients were allocated into group A, B and C randomly. Complete medical history and clinical findings of all the patients were recorded in the structured proforma prepared for the study. After obtaining detailed personnel history and thorough clinical examination, patients were diagnosed as moderate and severe grade of OSMF according to maximal mouth opening (MMO). MMO and tongue protrusion were measured using a vernier caliper and for burning sensation, the visual analogue scale (VAS) was used. MMO was measured from the incisal edge of the upper central incisor to the incisal edge of the lower central incisor tooth. Tongue protrusion was recorded from the incisal edge of the lower teeth. This was done by viewing the protruded tongue from the lateral aspect of the head and measuring the distance from the mesial contact area of the lower central incisors to the tip of the protruded tongue. Group A consisted of 10 patients, who were treated with intralesional injection of 2 ml dexamethasone (4 mg/ml) + hyaluronidase 1500 IU (biweekly) with physical exercise [Figure 2]. Group B consisted of 10 patients, who were treated with therapeutic ultrasound and soft tissue mobilization (biweekly) with physical exercise [Figure 3]and group C consisted of 10 patients, who were treated with therapeutic ultrasound and soft tissue mobilization (biweekly) without physical exercise [Figure 4]. For intralesional injection, the area with maximum numbers of fibrous bands was selected and for ultrasound therapy, ultrasound treatment device with 3 MHz frequency, continuous mode with an intensity of 2.5 W/cm2 was used [Figure 5]. The transducer of 5 cm diameter was applied over the cheeks bilaterally for 5 minute each, after which soft tissue mobilization was performed by fingertip and thumb tip by grasping the buccal mucosa with thumb placed outside and index finger inside for 3 min within tolerable pain limits. Mouth opening exercise was carried out by mouth opener device for minimum 10 minutes at chair side and tongue exercises (forward stretching of tongue, folding tongue to touch posterior part of palate and holding it for 15 second) were advised. All groups were treated for 4 weeks and all parameters of the present study in the form of maximal mouth opening, tongue protrusion and burning sensation was recorded before and after the intervention. All the patients were evaluated weekly and findings were compared with those at the beginning of the treatment.
Figure 2: Group A (a) Photograph showing intralesional injection of dexamethasone and hyaluronidase with insulin syringe at the site of fibrous bands; (b) Pre-treatment and (c) Post treatment photographs of mouth opening measurement

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Figure 3: Group B (a) Photograph showing treatment with ultrasound device (transducer of 5 cm diameter); (b) Soft tissue mobilization after ultrasound therapy with finger tip and thumb tip; (c) Pre-treatment and (d) Post treatment photographs of mouth opening measurement

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Figure 4: Group C (a) Pre-treatment and (b) post-treatment photographs of mouth opening measurement in patients treated with ultrasound without mouth opening exercise

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Figure 5: (a) Photograph of ultrasound device (continuous mode) of 3 MHz frequency with an intensity of 2.5 W/cm2 and vernier caliper to measure mouth opening (b) mouth opener device for chair side mouth opening exercise

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Statistical analysis

Statistical analysis of collected data was done using SPSS Statistics Version 23. The values were tabulated and evaluated statistically with paired t-test for intragroup comparison and one-way ANOVA for intergroup comparison at different time intervals. P values less than 0.01 were considered as highly significant, between 0.05 and 0.01 as significant, and more than 0.05 as non-significant.


   Result Top


In the present study out of 30 patients 27 were male (90%) and 3 were female (10%). The mean age was 29.8 years with maximum 13 patients (43.3%) were in 21–30 years age group [Chart 1]. The most common habit of commercial preparations observed was mawa (mixture of thin shaving of areca nut with some tobacco flecks and slaked lime) chewing [13 (43.3%)] followed by vimal (betel nut, tobacco, katha, lime stone) chewing [10 (33.3%)].



All the patients that participated in the study have shown statistically significant improvement in MMO at different time intervals (P = < 0.001). Mean difference in mouth opening after week 4 of treatment for groups A, B and C was 9.7 mm, 10.3 mm and 3.9 mm respectively. Maximum difference of MO (mouth opening) between before treatment and at the end of 4th week of treatment was noted more in group B [Chart 2].



Mean difference in tongue protrusion after 4-week treatment in OSMF patients of present study was 1.6 mm, 1.3 mm, 0.2 mm for groups A, B and C respectively which was statistically significant. (P = < 0.00) In groups A and B, the difference was more compared to group C [Chart 3].



Mean VAS score for all groups in present study was decreased significantly (P = < 0.05) which shows effectiveness of various treatment modalities to relive burning sensation in OSMF patients [Chart 4].




   Discussion Top


Oral submucous fibrosis (OSMF) is a chronic, progressive, debilitating, high-risk precancerous condition which was first reported by Schwartz in 1952. Schwartz used the term “atrophica idiopathica (tropica) mucosae oris.”[4],[9]

The etio-pathogenesis of OSMF is not completely understood so far but areca nut has been identified as a major etiological factor. Arecoline and tannin present in areca nut leads to increased collagen synthesis and its decreased breakdown.[4] In the present study, all patients had the habit of chewing commercially available areca nut and tobacco products with the most common being mawa (43.3%) and vimal (33.3%), which was in accordance with other studies.[3],[5],[6],[8]

The present study shows a definite male (90%) predominance. It is in accordance with the previous studies[3],[5],[8],[9] but in contrast to others where female predominance was observed.[7],[10] Maximum 13 OSMF patients (43.3%) were in the age group of 20–40 years with mean age of 29.8 years which was consistent with literature.[2],[3],[5],[6],[8] Higher males predominance may be due to easy product accessibility and changing lifestyles of the youngsters, peer influence, stress, addiction, etc.[5],[8]

All the patients participating in the present study showed improvement in mouth opening at the end of week 4, suggesting that all the treatment modalities used in this study were useful in management of OSMF. Improvement in mean mouth opening after 4 weeks of intervention was more in group B as compared to other groups, which was in accordance with other studies.[2],[5],[6],[11] This rapid improvement in group B is attributed to the therapeutic effect of ultrasound, which works on creating the extensibility of collagen fibers and to reduce inflammation, thereby promoting healing. Kneading and soft tissue mobilization is an effective form of massage therapy in improving the elasticity of fibrous tissues and mobilizing scar tissues, which in turn increase the blood flow to the area. Thus, it is useful in repair and regeneration of the tissue. In group C, only ultrasound therapy without exercise shows limited effect compared to other 2 groups because extensibility of fiber will become more after ultrasound therapy with physical exercise.

It was found that patients in group A had a mean improvement of mouth opening of 9.7 mm and which was almost similar to group B. Steroids act by opposing the action of soluble factors released by sensitized lymphocytes following activation by specific antigens steroids that act as immunosuppressive agents. It also prevents or suppresses inflammatory reactions thereby preventing fibrosis by decreasing fibroblastic proliferation and deposition of collagen.[3] Tongue protrusion showed some improvement in groups A and B compared to group C in the present study; these results were in accordance with Tyagi et al.[10] As per the study done by Guduru et al.,[8] the present study also used an extraoral therapeutic ultrasound device; hence, the improvement in tongue protrusion was minimal.

The reduction in VAS score for burning sensation in mouth was similar to the study conducted by Galchar et al.[12] The reason behind pain relief by ultrasound was directly influencing the transmission of painful impulses by eliciting changes within the nerve fibers and elevating pain threshold. On the other hand, indirect pain reduction occurs as a result of increased blood flow and increased capillary permeability to the affected area.[8]

Thus collectively, with a cessation of the betel-quid chewing habit, early start of these treatment regimens combined with daily mouth opening exercises were found to be necessary to manage OSMF cases in advanced stages of progression.


   Conclusion Top


Ultrasound therapy interventions definitely show a significant improvement in the patient's condition with no reported side effects. Hence, it should be included in the treatment protocol for patients with OSMF before planning for any other invasive surgical intervention.

Limitation and future prospects

Adjuvant treatment modalities by intralesional injection followed by ultrasound therapy in a large sample of different grades of OSMF patients with longer duration of follow up could reduce the effect of confounding factors. Longterm ultrasound therapy would have revealed better results but the patients' compliance was questionable.

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

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Jontell M, Holmstrup P. Red and white lesions of the oral mucosa. In: Glick M, Glick M, Ship JA, editors. Burket's Textbook of Oral Medicine. 11th ed. PMPH USA; 2015. p. 87-90.  Back to cited text no. 1
    
2.
Dani VB, Patel SH. The effectiveness of therapeutic ultrasound in patients with oral submucosal fibrosis. Indian J Cancer 2018;55:248-50.  Back to cited text no. 2
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Goel S, Ahmed J. Oral submucous fibrosis. J Cancer Res Ther 2015;113-118.  Back to cited text no. 3
    
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Arora A. Treatment modalities in oral submucous fibrosis: A review. J Adv Med Dent Sci Res 2019;7:11-5.  Back to cited text no. 4
    
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Tyagi H, Lakhanpal M, Dhillon M, Baduni A, Goel A, Banga A. Therapeutic ultrasound in OSMF. J Indian Acad Oral Med Radiol 2018;349-54.  Back to cited text no. 5
    
6.
Subramaniam AV, Subramaniam T, Agarwal N. Assessment of the effectiveness of antioxidant therapy (lycopene) and therapeutic ultrasound in the treatment of oral submucous fibrosis. Int J Pharm Ther 2014;5:344-50.  Back to cited text no. 6
    
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Haider SM, Merchant AT, Fikree FF, Rahbar MH. Clinical and functional staging of oral submucous fibrosis. Br J Oral Maxillofac Surg 2000;38:12-5.  Back to cited text no. 7
    
8.
Guduru H, Garlapati K, Solomon RV, Ignatius AV, Yeladandi M, Nithika Madireddy. Comparison of intralesional and ultrasound therapy in OSMF patients. J Indian Acad Oral Med Radiol 2019;31:11-6.  Back to cited text no. 8
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Ahmad MS, Ali SA, Ali AS, Chaubey KK. Epidemiological and etiological study of oral submucous fibrosis among Gutkha chewers of Patna, Bihar, India. J Indian Soc Pedod Prev Dent 2006;24:84-9.  Back to cited text no. 9
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Pindborg JJ, Mehta FS, Gupta PC, Daftary DK. Prevalence of oral submucous fibrosis among 50,915 Indian villagers. Br J Cancer 1968;22:646-54.  Back to cited text no. 10
    
11.
Vijayakumar M, Priya D. Physiotherapy for improving mouth opening & tongue protrution in patients with Oral Submucous Fibrosis (OSMF) – Case series. Int J Pharm Sci Health Care 2013;2:50-8.  Back to cited text no. 11
    
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Galchar P, Soni N, Bhise A. A comparative study of ultrasound and exercise versus placebo ultrasound and exercise in patient with oral submucous fibrosis. Indian J Phys Ther 2014;2:31-41.  Back to cited text no. 12
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]



 

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