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ORIGINAL ARTICLE
Year : 2022  |  Volume : 11  |  Issue : 1  |  Page : 69-73

Evaluation of the efficacy of collagen membrane for mucousal defect in oral sub mucous fibrosis


1 Department of Oral and Maxillofacial Surgery, Kothiwal Dental College and Research Centre, Moradabad, UP, India
2 Department of Prosthodontics Crown and Bridge, Kothiwal Dental College and Research Centre, Moradabad, UP, India
3 Department of Orthopaedic, Narayan Medical College and Hospital, Sasaram, Bihar, India
4 Department of Oral and Maxillofacial Surgery, Buddha Institute of Dental Science, Patna, Bihar, India

Date of Submission04-May-2021
Date of Decision04-Jun-2021
Date of Acceptance16-Jul-2021
Date of Web Publication23-May-2022

Correspondence Address:
Dr. Sourav Kumar
Kothiwal Dental College and Research Centre Moradabad - 244 001, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jdrntruhs.jdrntruhs_49_21

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  Abstract 


Background: Oral submucous fibrosis is well diagnosed as a premalignant condition. Through this article, an attempt was tried to improve the knowledge regarding surgical management which improves the existence expectancy of patients suffering from OSMF.
Materials and Methods: The study included 15 patients in the age group of 15 to 60 years with stage II, III and IVa of oral submucous fibrosis all of which underwent operation under general anesthesia to facilitate an increase in their mouth opening by excision of fibrous bands and placement of collagen membrane by the same operator. After surgery, all were given similar prescriptions for analgesics, antibiotics, and postoperative instructions. All patients were reviewed at 1st week, 2nd week, 3rd week till 6th months postoperatively.
Results: In this study, the mean age of occurrence of OSMF was 2nd to 3rd decade of life with males (86.6%) more commonly affected. The preoperative mouth opening was a mean value of 16.4 mm in all patients. At the first week postoperatively, a mean mouth opening of 24.96 mm was achieved which gradually increased to a mean mouth opening of 28.16 mm at the 2nd month with the help of rigorous physiotherapy. There was a slight gradual increase of mean mouth opening at consecutive months at 29.1 mm at the follow-up period of 6th months.
Conclusion: In our study, we noticed that surgical excision of fibrous bands and placement of collagen membrane provided us with satisfactory results, there was a significant increase in the mouth opening of the patients till the last follow-up month as compared to the preoperative mouth opening. However, to prove a more significant result, we need a larger sample size, as well as a longer follow-up for the establishment of the same.

Keywords: Collagen membrane, general anesthesia, oral submucous fibrosis


How to cite this article:
Dutt M, Kumar S, Nayak D, Khan M, Kumar S, Nayak N. Evaluation of the efficacy of collagen membrane for mucousal defect in oral sub mucous fibrosis. J NTR Univ Health Sci 2022;11:69-73

How to cite this URL:
Dutt M, Kumar S, Nayak D, Khan M, Kumar S, Nayak N. Evaluation of the efficacy of collagen membrane for mucousal defect in oral sub mucous fibrosis. J NTR Univ Health Sci [serial online] 2022 [cited 2022 Jun 26];11:69-73. Available from: https://www.jdrntruhs.org/text.asp?2022/11/1/69/345804




  Introduction Top


Oral submucous fibrosis (OSMF) has been well established in Indian medical literature since the time of Sushruta. In modern literature, this condition was first described by Schwartz in 1952. Joshi (1952) is credited to be the first person who described this condition and gave it the present term. This condition is predominantly seen in the Indian subcontinent as well as people of this origin settled elsewhere in the world.[1]

Various studies have suggested a multifactorial origin with a high incidence of the disease in association with consumption of the areca nut.[1],[2] Areca nut, Areca catechu, commonly known as betel nut or supari, plays a crucial dual role in the etiology of OSME. Arecoline, an alkaloid component of the areca nut, stimulates fibroblastic proliferation and collagen synthesis thus resulting in the formation of fibrotic bands resulting in trismus.[1] The clinical features such as excessive salivation, absent gustatory sensation, and limitation of mouth opening lead to difficulty in chewing, swallowing articulation, and poor oral hygiene. The oral mucosa appears pale, dense, with vertical fibrotic bands extending to the anterior tonsillar pillars.

A malignant transformation rate of 7.6% is observed in cases of oral submucous fibrosis.[3]

Various surgical procedures including excision of fibrous bands with or without graft have been used. Materials for grafting include skin or placental grafts, tongue flaps, lingual pedicle flaps, buccal fat pad grafts, and nasolabial flaps.

One of the biologic products is bovine-derived xenogenous collagen, a biologic plastic, which can be molded like wax into desired forms. Because of its easy availability, method of extraction, purification, and low antigenicity, it has been used under many clinical conditions as a temporary dressing material with favorable results.[4] Collagen membrane is used as in intraoral temporary wound dressing to promote hemostasis, relieving pain-induced granulation, and assist rapid epithelization at the wound site and prevent infection, contracture, scarring, donor site morbidity, and rejection of the graft.[5] Wounds left uncovered are prone to infection, contraction, and scarring with other clinical complications. Raw wounds in the oral cavity behave similarly; a need, therefore, arises to use a biologic cover to prevent these complications. Thus, collagen membrane can be one of the options for the surgical treatment of OSMF.

We used collagen membrane to cover the buccal defect after the excision of fibrous bands to enhance mouth opening in patients with oral submucous fibrosis. Collagen membranes are good enough to resist masticatory forces for a sufficient time, to allow granulation tissue to form, which appears uniformly.[4]

Hence, a study has been undertaken to establish the application of collagen membrane after fibrotic band excision for surgical management of oral submucous fibrosis.


  Aim Top


To evaluate the increase in mouth opening following surgery.


  Materials and Methods Top


In this trial, 15 patients underwent surgical management of OSMF as an application of collagen membrane after fibrotic band excision for oral submucous fibrosis. All of the subjects were evaluated preoperatively. Informed consent was obtained. Inclusion criteria were as follows – 1. Patients in the age group of 15 to 60 years with a mean age of 37.5 + years were included in the study, 2. Patients were included according to the presenting symptoms, sites of involvement, distribution of fibrous bands, clinical alterations in the mucosa, malignant transformation, and measurement of interincisal opening, 3. Patients falling under stage II, III & IVA (Khanna and Andrade) of oral submucous fibrosis were included in the study.

Patients suffering from any renal or hepatic disease, blood dyserasia, previous present gastric ulcers, heart disease, hypersensitivities, allergies, or idiosyncratic reactions to any study medications, pregnant or lactating females, history of diabetes mellitus, and patients not consenting to participate in the study were excluded.


  Surgical Technique Top


The operations were performed under general anesthesia with nasal intubation. The incisions were made with an electrosurgical knife along each side of the buccal mucosa at the level of the occlusal plane away from Stenson's orifice. An incision was carried posteriorly to the pterygomandibuiar raphe or anterior pillar of the fauces and anteriorly as far as the corner of the mouth, depending upon the location of the fibrotic bands which restricted mouth opening [Figure 1]. These fibrotic bands were always detectable by palpation. The wounds created were further freed by manipulation until no restrictions were felt. The mouth was then forced open with a mouth opener to an acceptable range of approximately 35 mm. The reconstructed collagen membrane was placed on bilateral buccal defects and secured with quilt sutures [Figure 2].
Figure 1: Incision

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Figure 2: Reconstructed collagen membrane was placed

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Postop instruction

All patients received Inj. amoxycillin + potassium clavulanate 1.2 gm and Inj. metronidazole 500 mg 8 hourly by the intravenous route for the first 4 days, and then medication was switched on to oral route for next 4 days, the patients were put on dexamethasone on the tapering doses for 3 consecutive days. Patients received analgesics, Injection voveran (Diclofenac sodium) 12th hourly for the first two days. Analgesics were stopped on the 3rd postoperative day. All patients were instructed to stop chewing betel nuts or other addictive habits. Patients were taught mouth opening exercises with a Heister's mouth opener or using ice cream sticks and were instructed to carry out this exercise 6 times a day.


  Results Top


A total of 15 patients reported to the the Department of Oral Maxillofacial Surgery to evaluate the increase in mouth opening following surgery and to assess the efficacy of collagen membrane as a biological dressing for mucosal defect following excision of fibrotic bnd.

The age of patients ranged from 21 to 52 years. A total of 6 (40%) patients each were in the age group 15–30 years, 6 (40%) patients were in 31-45 years, and 3 (20%) patients were in 46–60 years, respectively.

According to Khanna and Andrade's group of staging OSMF based on clinical features, 10 (66.66%) patients were in the group of stage III, whereas 5 (33.3%) patients belonged to group IVa [Table 1].
Table 1: Stage Wise Distribution of The Patients

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The preoperative mouth opening was in the range of 12–24 mm among 15 patients with a mean value of 16.4 mm after carried out procedure. Mouth opening was assessed postoperatively at 1st month (once weekly), 2nd month (twice weekly), 3rd month, 4th month, 5th month, and 6th postoperatively. After the release of fibrotic bands, a mean forced intra-operative mouth opening was 36.13 mm (mean). Mean postoperative mouth opening at 1st month was 24.96 mm, which was less than intraoperative mouth opening. The mouth opening was gradually increased to 28.16 mm at 2nd month, 28.8 mm at 4th month, 28.9 mm at 5th month, and 29.1 mm at 6th month postoperatively [Table 2].
Table 2: Mouth Opening of all The Patients at different Time Intervals (Mean)

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Statistical analysis

The statistical analysis was done using Statistical Package for Social Sciences (SPSS) Version 15.0 statistical Analysis Software. The values were represented in number (%) and mean ± SD. The following statistical formulas were used:

Mean: To obtain the mean, the individual observations were first added together and then divided by the number of observations. The operation of adding together or summation is denoted by the sign Σ.

The individual observation is denoted by the sign Y, the number of observations denoted by n, and the mean by X



No. of observations (n)


  Discussion Top


In 1952, Schwart first coined the term “atrophica idiopathica mucosa oris” to describe an oral fibrotic disease from Kenya.[1] Oral submucous fibrosis is a chronic disorder characterized by progressive fibrosis of the lining mucosa of the upper digestive tract involving the oral cavity, oropharynx, and frequently the upper third of the esophagus. This disease is most frequently found in India and is not uncommon in Southeast Asia (southern China, Taiwan, Malaya, Singapore, Indonesia, Vietnam, and Thailand).[3] It has a wide variety of etiological factors, among which the common and most accepted one is the concept of chewing areca nut tobacco in its various forms.

The aim of the treatment for oral submucous fibrosis is first, to advise patients to stop the habits and to provide good release of fibrosis with long-term results in terms of mouth opening. It is a well-established fact that in oral submucous fibrosis there is decreased vascularity to the affected region by fibrosis due to contraction and narrowing of the blood vessels as a result of increased pressure on them by fibrosis of tissue bands.

The use of collagen membrane in the treatment of OSMF is more suitable for juxtaposed defects of buccal mucosa and is increasingly becoming popular. Collagen, a well-known protein, has been widely used in medical applications.[5] Many natural polymers and their synthetic analogs are used as biomaterials, but the characteristics of collagen as a biomaterial are distinct from those of synthetic polymers mainly in its mode of interaction in the body. This reconstituted collagen also used in a study by Rastogi et al. (2009)[4] is cross-linked with tanning agents such as glutaraldehyde or chromium sulfate so that its tensile strength is improved, it becomes insoluble, its rate of resorption is slowed down, and its antigenicity is markedly lowered.

In our series, all patients gave a positive history of chewing some form of betel nut or tobacco or a combination of the common form being roasted betel nuts. Diagnostic criteria in our study were burning sensation of the mucosa, mucosal blanching resulting in marbled appearance and stiffness of oral mucosa, stomatitis, the sensation of dry mouth, alteration in taste, fibrosis of the oral mucosa followed by stiffness most commonly in the buccal mucosa, soft palate, and faucial pillars. Fibrotic bands run vertically in the cheek and circumferentially in the lips. The majority of these diagnostic features were observed in all our patients with varying severity. In the present study, the majority of subjects were male, i.e., 13 (86.6%), and there were 2 (13.5%) females. These observations were similar to those of Gupta P.C et al. (1988)[6] which demonstrated a high incidence OSMF in male patients but contradicts the study by Cannif J.P et al. (1981)[2] which showed female predominance. A high incidence of predominance in our sample size could be owing to the high incidence of betel nut chewing in males in the subcontinental region. In our study, the age of patients ranged from 21 to 52 years. A total of 6 (40%) patients each were in age groups 15–30 years, 6 (40%) patients were in 46–60 years, and 3 (20%) patients were in 46–60 years, respectively which conforms with the other studies that OSMF is generally seen in young to middle age group. Most of the patients who presented us with the disease were in 2nd to 3rd decades of life, this data corresponded with the data provided by Khanna et al. (1995).[1]

In our series of cases, preoperative mouth opening was less than 25 mm in 10 cases, whereas 5 cases had an interincisal mouth opening up to 15 mm only. The preoperative mouth opening was in the range of 8–24 mm, and the mean of the preoperative mouth opening was found to be 16.4 mm in our study group. In our study, we had used a collagen membrane to cover the mucosal defect after the excision of the bands, because of its easy availability and method of extraction, and its low antigenicity. After the release of fibrotic bands, a mean intraoperative mouth opening of 36.13 mm was achieved which in comparison to the study of Yeh C.Y et al. (1996)[7] was found to be almost similar. Postoperatively, the 1st month mean mouth opening of 24.96 mm was achieved which was again nearly similar to the mouth opening achieved in the study by Chung-Kan Tsao et al. (2010)[8] where the more extensive microvascular study was performed.

Mouth opening gradually increased to 29.1 mm, the mean mouth opening at 6 months follow up, which was almost similar to the measurement achieved by the study by Yeh C.Y et al. (1996)[7] and Chung-Kan Tsao et al. (2010).[8] Mouth opening achieved after the surgery was satisfactory there was a slight decrease in mouth opening from 1st month to 6th month follow up as compared to the intraoperative mouth opening achieved during surgery. This was observed due to the muscle pull of the elevator muscles of mastication including temporalis muscle therefore it may be advised to do bilateral coronoidectomy or coronoidotomy (attachment of temporalis muscle) in a single-stage procedure to further improve mouth opening postoperatively as done in other studies including the study by Borle et al. (2008).[3] A mean increase of 12.7 mm from the preoperative measurement to the last follow up was observed in our study which is similar to the study by Ych C.Y et al. (1996)[7] and Chung-Kan Tsao et al. (2010)[8] where coronoidectomy or coronoidotomy was not performed. No relapse was encountered in any of the patients, even at the last follow-up period of 6 months.

From the foregoing discussion, we in our study found that collagen membrane showed good results on the application in patients with advanced stages of OSMF.

However, to prove a more significant result, we need a larger sample size as well as a longer follow-up for the establishment of the same.


  Conclusion Top


In our study, we noticed that surgical excision of fibrous bands and placement of collagen membrane provided us with satisfactory results, there was a significant increase in the mouth opening of the patients till the last follow-up month as compared to the preoperative mouth opening. We believe with our results that although we achieved significant mouth opening postoperatively. It is beneficial to perform bilateral coronoidectomy in a single-stage procedure to further enhance the postoperative mouth opening. Collagen membrane was found to be very effective in all the subjects, and it provided us satisfactory results as an intraoral wound dressing material. However, to prove a more significant result, we need a larger sample size as well as a longer follow-up period for the establishment of the same.

Ethical approval

Ethical consent was obtained by the Institutional ethics review board, KDCRC Moradabad with issue no. KDCRC/ETH/OMFS/2010/03.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for 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.
Khanna JN, Andrade NN. Oral submucous fibrosis: A new concept in surgical management. Report of 100 cases. Int J Oral Maxillofac Surg 1995;24:433-9.  Back to cited text no. 1
    
2.
Canniff JP, Harvey W. The aetiology of oral submucous fibrosis: The stimulation of collagen synthesis by extracts of areca nut. Int J Oral Surg 1981;10(Suppl 1):163-7.  Back to cited text no. 2
    
3.
Borle RM, Nimonkar PV, Rajan R. Extended nasolabial flaps in the management of oral submucous fibrosis. Br J Oral Maxillofac Surg 2009;47:382-5.  Back to cited text no. 3
    
4.
Rastogi S, Modi M, Sathian B. The efficacy of collagen membrane as a biodegradable wound dressing material for surgical defects of oral mucosa: A prospective study. J Oral Maxillofac Surg 2009;67:1600-6.  Back to cited text no. 4
    
5.
Lee CH, Singla A, Lee Y. Biomedical applications of collagen. Int J Pharm 2001;221:1-22.  Back to cited text no. 5
    
6.
Gupta D, Sharma SC. Oral submucous fibrosis--a new treatment regimen. J Oral Maxillofac Surg 1988;46:830-3.  Back to cited text no. 6
    
7.
Yeh CJ. Application of the buccal fat pad to the surgical treatment of oral submucous fibrosis. Int J Oral Maxillofac Surg 1996;25:130-3.  Back to cited text no. 7
    
8.
Tsao CK, Wei FC, Chang YM, Cheng MH, Chwei-Chin Chuang D, Kao HK, et al. Reconstruction of the buccal mucosa following release for submucous fibrosis using two radial forearm flaps from a single donor site. J Plast Reconstr Aesthet Surg 2010;63:1117-23.  Back to cited text no. 8
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]



 

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Abstract
Introduction
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Materials and Me...
Surgical Technique
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