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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 9  |  Issue : 1  |  Page : 1-5

A comparative study on the use of antioxidants and intralesional steroid infiltration in oral submucous fibrosis


Department of ENT and Head and Neck Surgery, Bhima Bhoi Medical College, Balangir, Odisha, India

Date of Submission30-Dec-2020
Date of Decision03-Jan-2021
Date of Acceptance04-Jan-2021
Date of Web Publication30-Mar-2021

Correspondence Address:
Dr. Satyajit Mishra
Ainthapali, Kainsir Road, Sambalpur - 768 004, Odisha
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mjhs.mjhs_32_20

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  Abstract 


Background: Oral submucous fibrosis (OSMF) affects all age groups in Orissa. Rampant use of tobacco, gutka, and betel chewing made it a significant public health problem. Various modalities of treatments have been tried to ameliorate consequences of disease including antioxidants, local and systemic steroid, physiotherapy alone or with assisted devices, placental extract injection, and split skin grafting with varying success rate.
Objective: The objective of the study was to compare effect of antioxidants and intralesional steroid infiltration in OSMF.
Materials and Methods: Hospital-based prospective study was carried out among fifty patients presenting with OSMF. Only Stage two patients with Grade 2 and 3 trismus were included. History, clinical examination, and punch biopsy were taken. They were divided into two groups of 25 each irrespective of age and sex. Patients in Group A were given injection hyaluronidase (1500 IU) mixed with triamcinolone (40 mg/ml). It was injected submucosally once a week for 8 weeks over multiple sites in oral cavity. Patients in Group B were given oral antioxidant capsule (containing lycopene 4 mg, zinc 7.5 mg, and selenium 35 mg) once daily for 8 weeks. All patients were followed up for 8–12 weeks at weekly intervals and then monthly once for 1 year.
Results: Majority belonged to 26–35 years. Majority were consuming areca nut with Pan (52%). Burning sensation on taking food and trismus were common symptoms. Most common sign was fibrosis (70%). Injection hyaluronidase (1500 IU) mixed with triamcinolone (40 mg/ml) injected submucosally once a week for 8 weeks over multiple sites was significantly effective in trismus compared to oral antioxidant capsule daily once for 8 weeks.
Conclusion: Injection hyaluronidase (1500 IU) mixed with triamcinolone (40 mg/ml) injected submucosally once a week for 8 weeks over multiple sites was more effective than oral antioxidant capsule daily once for 8 weeks.

Keywords: Antioxidant, oral submucous fibrosis, steroid injection


How to cite this article:
Mishra S. A comparative study on the use of antioxidants and intralesional steroid infiltration in oral submucous fibrosis. MRIMS J Health Sci 2021;9:1-5

How to cite this URL:
Mishra S. A comparative study on the use of antioxidants and intralesional steroid infiltration in oral submucous fibrosis. MRIMS J Health Sci [serial online] 2021 [cited 2021 Jun 20];9:1-5. Available from: http://www.mrimsjournal.com/text.asp?2021/9/1/1/312605




  Introduction Top


Oral submucous fibrosis (OSMF) has been well established in Indian medical literature since the time immemorial. Even Sushrut in about 2500 BC had described it as a disease entity. This a chronic and painfully debilitating disease characterized by the presence of palpable fibrous bands, generalized fibrosis of oral cavity, and trismus.[1] It presents with burning sensation, vesicle eruption, and ulcerations too. It is quite prevalent in the Indian subcontinent and especially in southern Orissa.

It is divided into three stages:[2]

  • Stage 1: Stomatitis, erythematous mucosa, vesicles, and ulcers
  • Stage 2: Ruptured vesicles leading to fibrosis, vertical and circular fibrous bands, and trismus is present
  • Stage 3: Leukoplakia as a sequel, gradual involvement of tongue, palate, etc.


Most of the patients are habituated to chewing tobacco along with consumption of areca nuts, gutka, and betel chewing, etc., The most important remedy is giving up the habit of chewing betel quid containing areca nut, avoiding other local irritants such as hot and spicy food, alcohol, and smoking. The most common mode of treatment has been using of steroid in various forms. Other modes of treatment are antioxidant orally for several months or years, local injection of placental extract, oral zinc, pentoxyphylline, and grafting of various tissue, etc.

Local injection of hyaluronidase (1500 IU) triamcinolone (10 mg) biweekly had been used in various centers with satisfactory clinical improvement in the patients. The problem with the treatment is that dose and duration of treatment has not been standardized. Many centers use the above combination for at least 3 to 6 months. However, it becomes difficult to do a follow-up of the patients for such a duration and many patients lose the motivation to continue with treatment as it is a painful procedure and the clinical improvement is slow to happen.

Hence, a study was planned to see the efficacy by comparing outcome between treatment with injection (local) of hyaluronidase (1500 IU) with triamcinolone (40 mg/ml) weekly once for 8 weeks versus oral antioxidant capsule (containing lycopene, zinc, and selenium) consumption once daily for 8 weeks.


  Materials and Methods Top


This was a hospital-based prospective study. A total of fifty patients presenting with OSMF to Department of ENT and Head and neck Surgery SLN Medical College, Koraput, from January 2018 to July 2019 were included in the study.

After diagnosis, patients were classified as per Pindberg[2] staging (depicted in introduction). Trismus of Stage 2 was graded as below after measuring by caliper.

  • Normal mouth opening: >50 mm inter incisor gap
  • Grade 1 (mild trismus): 50–30 mm inter incisor gap
  • Grade 2 (moderate trismus): 29–16 mm inter incisor gap
  • Grade 3 (severe trismus): <15 mm inter incisor gap.


In this study, only Stage two patients with Grade 2 and 3 trismus were included in the study. Prior informed consent was taken from them. The patients after a through history collection regarding intake of chili, areca nut, pan masala, betel quid, alcohol, and smoking were clinically examined for general health status, and punch biopsy was taken to confirm diagnosis as well as rule out leukoplakia and malignancy. They were divided into two groups of 25 patients each irrespective of age and sex.

  • Group A: Twenty-five patients were in Group A who were given injection Hyaluronidase (1500 IU) mixed with Triamcinolone (40 mg/ml). It was injected submucosally once a week for 8 weeks over multiple sites in oral cavity with insulin syringe and needle. They were instructed not to rinse their mouth for at least 1-h postinjection
  • Group B: Twenty-five patients were in Group B who were given oral antioxidant capsule (containing lycopene 4 mg, zinc 7.5 mg, and selenium 35 mg) once daily only were administered daily for 8 weeks.


The patients were followed up for 8–12 weeks at weekly intervals and then monthly once for 1 year.

Exclusion criteria

  1. Patients with systemic diseases such as diabetes, hypertension, or any other disease that contraindicates steroid consumption or having any malignancy anywhere in body were excluded from the study.


Ethical considerations

Institution Ethics Committee permission was obtained. Informed consent was taken. All patients were given standard management care and health education to avoid tobacco products use.

Statistical analysis

The data entered in the Microsoft Excel Sheet and analyzed using Epi Info statistical software Centers for Disease Control and Prevention, Atlanta, Georgia, USA. Chi-square test for proportion and t-test for mean values were applied. P < 0.05 was taken as statistically significant.


  Results Top


[Table 1] shows distribution of study subjects as per age and sex. Males were more than females 92% versus 8%. The study revealed that a majority of patients to be in the age group of 26–35 years, i.e., 26 were male and 4 were females.
Table 1: Distribution of study subjects as per age and sex

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[Table 2] shows distribution of study subjects as per predisposing factors. Majority were consuming Areca nut with Pan (52%) followed by Pan masala (Gutka) in 40% of the cases.
Table 2: Distribution of study subjects as per predisposing factors

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[Table 3] shows distribution of study subjects as per symptoms. Burning sensation on taking food as well as decreasing mouth opening (trismus) were the most common symptoms being noted in all case in this study. Dry sensation in mouth (xerostomia) in 65% and ulcer in 35% were next predominant symptoms.
Table 3: Distribution of study subjects as per symptoms

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[Table 4] shows the distribution of study subjects as per signs. In this study, trismus, blanching of mucosa, and fibrous bands were seen in all patients. Ulceration, fibrosis along faucial pillars, and restricted tongue movement were found in 35%, 70%, and 62% of cases, respectively.
Table 4: Distribution of study subjects as per signs

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[Table 5] shows the distribution of study subjects as per investigations and histopathology findings. Fifty-six percent of the patients were found to be anemic, while no one was positive for HIV or VDRL. All tested normal for routine urine examination. On histopathology, it was observed that all cases were having OSMF.
Table 5: Distribution of study subjects as per investigations and histopathology findings

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[Table 6] in the moderate grade of disease, out of fifty patients, 25 were treated with injection hyaluronidase (1500 IU) mixed with triamcinolone (40 mg/ml) injected submucosally once a week for 8 weeks over multiple sites. All of them reported relief of burning sensation, while 88% (22 out of 25) had improved mouth opening (Group A). Rest 25 were treated with oral antioxidant capsule daily once for 8 weeks. Of them, all reported relief of burning sensation, while 56% (14 out of 25) had improved mouth opening in Group B. Thus, injection hyaluronidase (1500 IU) mixed with triamcinolone (40 mg/ml) injected submucosally once a week for 8 weeks over multiple sites has been found to be more effective in mouth opening symptom compared to oral antioxidant capsule daily once for 8 weeks. Both the treatment modalities were comparable in the relief of other symptoms.
Table 6: Comparison of treatment modalities for oral submucous fibrosis

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[Table 7] shows histopathological staging: pre- and post-treatment. Histopathological investigation was done in thirty willing patients posttreatment (15 from each group) all of the in both groups revealed improvement of their histopathological grading. The staging was done according to the staging by Pindberg.[2]
Table 7: Histopathological staging: pre and post treatment

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  Discussion Top


In our study, the peak age incidence was found to be 26–35 years in both sexes. Borle and Borle[3] had reviewed 326 such cases over a 7-year period in 1991 and had found peak age incidence of 20–15 years. As far as sex incidence is concerned, male preponderance of 9:1 was found in our study. This might be due to the wide spread use of gutka and betel in male population as compared to female ones. This may be due to more outdoor activity by male population.

As regard predisposing factors, areca nuts were the most common factor in maximum of our cases. Pindberg[2] had similar finding. Murti et al.[4]. in 1995 studied reviewed 275 patients over a 5-year period, and they had compared results of various studies undertaken in India, Pakistan, and South Africa and found areca nuts taken in isolation or with pan masala, gutka, etc., as a major predisposing factor. Similar was the finding of Maher et al.[5] In a study by Van Wyk et al.[6] in 1994 out of 122 patients studied, burning sensation in mouth and dryness of mouth were predominant symptoms in majority of patients. This is identical to our finding.

Khanna and Andrade[7] had found trismus, blanched mucosa, and fibrous bands in 97% of their cases. In our study, blanching of mucosa and fibrous bands were seen in all patients.

Anemia was the significant hematological finding in our series.

Lai et al.[8] had treated fifty patients with moderate OSMF with steroid-Hyaluronidase injections and found improvement in burning sensation in 95% and relief from ulceration/vesiculation in 90% of cases. Mouth opening improved in 83.5% of their cases. Khanna and Andrade[7] had treated 25 out of 100 of their cases (mod) with injection of triamcinolone. In our series, 100% improvement or alleviation of burning sensation and 95% improvement in mouth opening was seen in those treated with injection hyaluronidase mixed with triamcinolone.

All patients treated with antioxidants reported relief of burning sensation, while 55% (13 out of 25) had improved mouth opening. Saran et al.[9] noted burning sensation at baseline (1st visit) in 65.83% ± 3.98% (VAS) which reduced to 47.3% ± 33.95% (VAS) on the 15th day, showing a gradual decline in the burning sensation. After 2 months, there was marked decline in mean burning sensation when compared with the baseline. The burning sensation completely reduced after 3 months treatment period. Posttreatment, there was complete cessation of burning sensation.


  Conclusion Top


Submucous fibrosis is a debilitating disease assuming an endemic picture in Southern Odisha where this college is located. A total of 50 patients presenting with OSMF in the Department of ENT and Head and neck Surgery, S.L.N. Medical College, Koraput, between January 2018 and July 2019 were included in the study. Male preponderance (9:1) with peak age incidence between 26 and 35 years was seen in our study. While burning sensation in mouth and reduced mouth opening was the most common symptoms, trismus, blanched mucosa, and fibrous band were common signs. The patients were divided into two groups, and they were treated with combination of hyaluronidase and triamcinolone injection and antioxidant capsule (containing lycopene, zinc, and selenium). Patients treated with injection hyaluronidase and triamcinolone reported appreciable improvement in their symptoms and signs as well as histopathological grading as compared to those treated with antioxidant capsule.

As this condition has much morbidity and a predisposition to malignant transformation, patients should be encouraged for giving up unhealthy habits and motivated to go for early treatment.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Gupta PC, Sinor PN, Bhonsle RB, Pawar VS, Mehta HC. Oral submucous fibrosis in India: A new epidemic? Natl Med J India 1998;11:113-6.  Back to cited text no. 1
    
2.
Pindberg JJ. Oral sub mucous fibrosis: A review. Ann Acad Med Singap 1989;18:603-7.  Back to cited text no. 2
    
3.
Borle RM, Borle SR. Management of oral submucous fibrosis: A conservative approach. J Oral Maxillofac Surg 1991;49:788-91.  Back to cited text no. 3
    
4.
Murti PR, Bhonsle RB, Gupta PC, Daftary DK, Pindborg JJ, Mehta FS. Aetiology of oral submucous fibrosis with special reference to the role of areca nut chewing. J Oral Pathol Med 1995;24:145-52.  Back to cited text no. 4
    
5.
Maher R, Lee AJ, Warnakulasuriya KA, Lewis JA, Johnson NW. Role of areca nut in the causation of oral submucous fibrosis: A case-control study in Pakistan. J Oral Pathol Med 1994;23:65-9.  Back to cited text no. 5
    
6.
Van Wyk CW, Grobler-Rabie AF, Martell RW, Hammond MG. HLA-antigens in oral submucous fibrosis. J Oral Pathol Med 1994;23:23-7.  Back to cited text no. 6
    
7.
Khanna JN, Andrade NN. Oral sub mucous fibrosis: A new concept in surgical management. Int J Oral Maxillofacial Surg 1995;24:433-9.  Back to cited text no. 7
    
8.
Lai DR, Chen HR, Lin LM, Huang YL, Tsai CC. Clinical evaluation of different treatment methods for oral submucous fibrosis. A 10-year experience with 150 cases. J Oral Pathol Med 1995;24:402-6.  Back to cited text no. 8
    
9.
Saran G, Umapathy D, Misra N, Channaiah SG, Singh P, Srivastava S, et al. A comparative study to evaluate the efficacy of lycopene and curcumin in oral submucous fibrosis patients: A randomized clinical trial. Indian J Dent Res 2018;29:303-12.  Back to cited text no. 9
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