DIODE LASER TREATMENT IN ORAL SUBMUCOUS FIBROSIS.

DIODE LASER TREATMENT IN ORAL SUBMUCOUS FIBROSIS.
(KEM-PUNE STUDY)
Dr.K.K.DESARDA.
Abstract:
Oral submucous fibrosis (OSMF) is a high-risk pre-cancerous condition characterised by slowly progressive chronic fibrotic disease of the oral cavity and oropharynx, in which the oral mucosa loses its elasticity and develops fibrous bands, which ultimately leads to difficulty in opening the mouth. The malignant transformation rate of oral submucous fibrosis is as high as 7.6%. A wide range of treatments such as medical management, surgical therapy and physiotherapy have been attempted in the past with varying degrees of benefit, but none of them have been proved to be a conclusive method of treatment. . There are very few reports to correlate the clinical stage to histopathological grading in OSMF.The aim of our study was to relive trismus caused by submucous fibrosis,to evaluate the efficacy of diode laser therapy without any grafting procedures, and to maintain mouth opening with props physiotherapy.
 A hospital-based study was conducted on 65 OSMF cases who visited ENT dept. KEM Hospital Pune from 1990 -1996. A detailed history of each patient was recorded along with a clinical examination. Biopsy was performed for histopathological correlation.We have  tried all modalities like diathermy excision,skin grafts.tongue flaps,palatal flaps but without much  benefits in improving trismus for our patients  and  lastly  we adopted  Diode surgical therapy  with spring props for physiotherapy  which proved excellent  treatment in improving trismus.
Key words: submucous fibrosis, Diode laser,props,skin grafts,tongue flaps.
Email:kdesarda@gmail.com
Adress: Dr.K.K. desarda.
Prof.Emeritus & Head Otolaryngology,
KEM Hospital’Pune, India.
Inroduction:
On the Indian subcontinent, the use of smokeless tobacco in various forms is very popular. This habit, which usually involves the chewing of a betel quid (combined areca nut, betel leaf, tobacco and slack lime), has led to the development, in a large proportion of users, of a unique generalized fibrosis of the oral soft tissues, called oral submucous fibrosis.The condition is found in 10/1,000 adults in rural India and as many as 5 million young Indians are suffering from this precancerous condition as a result of the increased popularity of the habit of chewing pan masala.  Pan masala is a mixture of spices including, betel nuts, catechu, menthol, cardamom, lime and others.  It has a mild stimulating effect and is often eaten at the end of the meal to help digest food and feel comfortable.
Oral submucous fibrosis is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the submucosal tissues (lamina propria and deeper connective tissues).  Oral submucous fibrosis results in marked rigidity and an eventual inability to open the mouth.  The buccal mucosa is the most commonly involved site, but any part of the oral cavity such as the soft palate, pterygomandibular raphe, the anterior pillars of fauces and even the pharynx can be involved.
 The treatment of patients with oral submucous fibrosis depends on the degree of clinical involvement. If the disease is detected at a very early stage, cessation of the habit is  sufficient. Most patients with oral submucous fibrosis present with moderate-to-severe disease which is irreversible. Medical treatment is symptomatic and predominantly aimed at improving mouth opening.. We have  treated stage II  with medical treatment and injection kenacort for six weeks and  Stage III  & iv with severe fibrosis + trismus + dysphagia with Dioded laser therapy and achieved excellent results with inter-incisor opening ranging between 32 to 36 mm .
Because of developments in Diode Laser technologies, it has found great applications in surgery due to improved power and precise controllability. It has found great applications in oral surgery practice as well as in other areas. By changing the wavelengths we can control the energy levels and other desired properties that determine incision quality and coagulation parameters.
PATHOGENESIS OF ORAL SUBMUCOUS FIBROSIS:
    ;

Diode lasers built with semiconductor materials are portable and very compact in size and can be used in different modes such as pulsed or continuous mode. Diode laser surgery can be successfully used in surgical treatment of Submucous fibrosis. On the Indian subcontinent, the use of smokeless tobacco in various forms is very popular. This habit, which usually involves the chewing of a betel quid (combined areca nut, betel leaf, tobacco and slack lime), has led to the development, in a large proportion of users, of a unique generalized fibrosis of the oral soft tissues, called oral submucous fibrosis.The condition is found in 10/1,000 adults in rural India and as many as 5 million young Indians are suffering from this precancerous condition as a result of the increased popularity of the habit of chewing pan masala.  Pan masala is a mixture of spices including, betel nuts, catechu, menthol, cardamom, lime and others.  It has a mild stimulating effect and is often eaten at the end of the meal to help digest food and as a breath mint.1
Oral submucous fibrosis is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the submucosal tissues (lamina propria and deeper connective tissues).  Oral submucous fibrosis results in marked rigidity and an eventual inability to open the mouth.  The buccal mucosa is the most commonly involved site, but any part of the oral cavity such as the soft palate, pterygomandibular raphe, the anterior pillars of fauces and even the pharynx can be involved.The condition is well associated with areca nut chewing; a habit practiced predominately in Southeast Asia and India. Worldwide, estimates of oral submucous fibrosis indicate that 2.5 million people are affected, with most cases concentrated on the Indian subcontinent, especially southern India.  The rate varies from 0.2-2.3% in males and 1.2-4.5% in females in Indian communities.  The migration of endemic betel quid chewers has also made oral submucous fibrosis a public health issue in many parts of the world, including the United Kingdom, South Africa, and many Southeast Asian countries.
A variety of aetiological factors including capsaicin, betal nut alkaloids, hypersensitivity, autoimmune genetic predisposition  and malnutrition have been suggested by various authors.The importance of this disease lies in its inability to open the mouth and dysplasia giving rise to malignancy.  The incidence of malignant change to squamous cell carcinoma in patients with OSMF ranges from 2 to 10%. Submucous fibrosis typically affects the buccal mucosa, lips, retromolar areas and the soft palate. Occasional involvement of the pharynx and esophagus is seen. Early lesions present as a blanching of the mucosa, imparting a mottled, marble-like appearance. Later lesions demonstrate palpable fibrous bands running vertically in the buccal mucosa and in a circular fashion around the mouth opening or lips.  As the disease progresses the mucosa becomes stiff, causing difficulty in eating and considerably restricting the patient's ability to open the mouth (trismus). If the tongue is involved, it becomes stiff and  atrophic.
Mucosal petechiae are seen in more than 10% of cases and most patients complain of a burning sensation, often aggravated by spicy foods.  Salivary flow is diminished and blotchy melanotic mucosal pigmentation is often seen. More than a fourth of affected persons develop precancerous leukoplakia of one or more oral surfaces. Once present, oral submucous fibrosis does not regress, either spontaneously or with cessation of betel quid chewing.Histologic findings in oral submucous fibrosis are generally characterized by diffuse hyalinization of the subepithelial stroma, atrophic epithelium and intercellular oedema, with or without keratosis, epithelial dysplasia, chronic inflammation and fibrosis in the minor salivary glands in the area of quid placement; and atrophy of the underlying muscle.
MATERIALS AND METHODS
  A total of 65 histologically proven cases of advanced oral submucous fibrosis having a mouth opening of less than 10 mm were treated by Diode laser excision. The procedure involved (1) bilateral release of fibrotic bands  .(2)extraction of bilateral upper and lower molars .3) Temporary acrylic prosthesis insertion between upper and lower molars bilaterally. 4) after six weeks patients were given spring prosthesis for extensive physiotherapy. 5)  Pre and post operative inter-incisors distances were measured  by caliper and recorded.6) supportive IV fluids, vitamins. and antioxidants therapy was continued for further three months. 7) Regular followup was done and results were assessed by comparing the  different modalities  responses in preoperative & postoperative maximum mouth opening.8) No grafting  procedures were  done in our series for the scarred tissue. 9) Post op healing was excellent.
        TABLE-1, Age group & sex Ratio:
       
     
  TABLE-2. Clinical staging and grouping:
Group I Earliest stage witht mouth opening limitations with an interincisal distance of greater than 35 mm.
Group II Patients with an interincisal distance of 26-35 mm.
Group III Moderately advanced cases with an interincisal distance of 15-26 mm.
Group IVA   Trismus is severe, with an interincisal distance of less than 10 mm
Group IVB Disease is most advanced, with  dysphagia  & premalignant and malignant changes in the mucosa
 
      TABLE-3 Grouping of Different modalities treatment result wise:
Grouping Procedure Cases Result
Group 1 Simple diatheramy excision                 25 cases             Triusmus opening short term with scarring
Group 2 Skin grafting                                       15 cases             High failure because of flap necrosis
Group 3       Tongue flaps                                       10 cases             Initial results good but very cumbersome for pts. Tongue flap necrosis, speech problems
Group 4 Diode laser therapy                           15 cases             Excellent long term results with improved                                    

Pre-Operative pictures of OSMF
                                       
Early branching in OSMF                Depapilliation of Tongue             severe blanching of tongue                   Bud-like uvula in OSMF        
                                                                   
                                     
        Buccal Lesion                                  Lower lip lesion                                Tongue lesion                              Retromolar lesion.

      Diode Laser Procedure:.

Under GA with tonsillectomy position the mouth gag(Boyle Davis) is inserted inthe oral cavity and the last upper and lower molars on either sides extractedand haemostasis secured. Next with Diode Laser the fibrotic bands from retromolar region to soft palate ,anterior and posterior tonsillar pillars and uvula were excised.Laser beam with ideally 5 watt power is directed. to the fibrotic bands .The excision of fibrous bands was followed by forcible separation of mucosa.using  Boyl davis gag  and oral cavity  opening stretched .at its maximum..After complete haemostasis the oral cavity is cleaned and temporary acrylic prosthesis is inserted  bilaterally between the last  upper and lower molars., and maintained for full 10 days.Post operative Ryles tube feedig continued for ten days . During the post op period  oral hyegine was mainted. After the oral mucosa has healed well ,the patients were given  spring props for for extensive physiotherapy.for further six weeks.All Patients were instructed to stop chewing betel nuts or other addictive habits. Patients were taught mouth opening exercises with this spring props six to eight times day along with chewing gums exercises.The inter- inscisor measurement were recorded. All patients were given i.v.antibiotics,anti inflammatory drugs for controlling the oral sepsis and pain . Patients were followed at an interval of 2 months, 6 months and 1 year where by interincisor distance was measured and documented..
Results
In our series  65 patients were studied from age 16 years to 60 years (Mean 32years) who were habitual betel nut chewers. Males had preponderance of 68%and females of 32%. The Mean maximum mouth opening of the patients preoperatively was 10 mm. The Mean intra operative interincisor distance after fibrotic band excision was 32mm. Two months postoperatively the average mouth opening was 34 mm.and at 6 months 36 mm, and at 1 year 34mm. Patients were very happy and satisfied after this treatment.Since there is no effective treatment for oral submucous fibrosis and the conditionis  is irreversible  we have decided to adopt to Diode laser therapy which gave excellent results. All patients were kept for periodical observation and  surface leukoplakias are handled by close follow-up and  repeat biopsies for malignment change.

Submucous Fibrosis pictures showing post-operative
                                                     
  Diode laser instrument            Pre-surgical Markings             Intra of Temporary prosthesis                   Post of spring prosthesis       Post operative final opening    
     Discussion
Oral submucous fibrosis is a chronic debilitating disease associated with restricted mouth opening and poor oral hygiene.   The treatment aims at good release of fibrosis and provides long term results in terms of mouth opening.  The various conservative treatments with intralesional injections of steroids,  (kenacort) ,hyaluronidase, placental extract and physiotherapy are not beneficial to provide a long-term effect in advanced cases of oral submucous fibrosis   Surgical intervention is required in these cases.  The surgical treatment commonly followed is the release of bilateral fibrotic bands with  surgery and various grafts, tongue flaps, etc were tried but not much of benefit.
A mucosal graft is the best treatment for oral submucous fibrosis, as it is ideal graft to cover the oral mucosa, but is limited by the quantity of oral mucosal available for grafting.  Thick mucosa taken from the cheek may result in scar formation, whereas a uniform thin graft removed with a microtome from the cheek is costly and complicated.  Split-skin grafting has been tried but it has a high failure rate as fibrotic areas have less vascular supply besides retaining the coloration of skin.  Also seen is the growth of hair and sweat glands.  Skin is not suitable for grafting in elderly people due to atrophy and inelasticity.
A nasolabial flap has also been used by some surgeons and has a good survival rate, but sometimes it may be too small to cover the whole defect.  It also causes a visible scar on the face and requires a second surgery for division.   Tongue flaps are bulky and when used bilaterally causes disarticulation, dysphagia and increases the chance of aspiration.   In addition, the tongue is involved with the disease process in 38% cases   The use of bilateral, small, bipaddical radial forearm flaps for reconstruction of bilateral buccal defects requires two flaps with two microsurgeries.  The procedure is more time consuming and technically demanding, and it involves two forearm donor sites with sacrifice of the radial arteries in both the right and left hands.  Island palatal flaps again have limitation to reach posteriorly.
Of the 65 cases of OSMF studied, males were more than females. A literature survey shows a wide variation in age and sex distribution of OSMF. Some of the epidemiological surveys in India have shown a female predominance in the occurrence of this entity. A male predominance in OSMF cases was shown by Sinor et al.in India. We also observed a male predominance and the male to female ratio was 6:1. Half of the study population was in the age group of 20-29 years. This observation is different from that of Pindborg et al. who reported the maximum number of OSMF cases in the age group of 40-49 years in their study. Increase in the chewing habit of the areca nut without any tobacco and the use of various commercial products containing areca nut may explain the decrease in the age of OSMF cases due to various chewing habits. The mean age of occurrence was lower in males than in females and the difference was statistically significant (P<0.009).

Recent epidemiological studies in India and evidence from Indians living in South Africa point to the habit of chewing areca nut as the major aetiological factor of OSMF. In recent years, commercial preparations like paanmasala have become available in India and abroad. The main ingredient of these products is areca nut along with lime and catechu wrapped in a betel leaf with or without tobacco. Many patients with OSMF give a history of chewing paanmasala for very long time.
Seventy-five per cent of the patients in stage II had a habit of chewing commercially available areca nut products-"Paanmasala" and 50% of the total study population were in the age group of 20-29 years. It has been documented that paanmasala chewing was preferred by people in younger age groups (11-30 years). In addition, onset of OSMF changes occurred earlier with paanmasala chewing compared with areca nut / quid chewing. Absence of betel leaf, which has anti-oxidant properties and a consequently higher dry weight proportion of areca nut were responsible for early development of OSMF. These findings are of great concern because younger individuals are at greater risk as it has been well established that OSMF is a premalignant and crippling condition of the oral mucosa.
 The treatment aims at good release of fibrosis and provides long term results in terms of mouth opening.  The various conservative treatments with intralesional injections of steroids, hyaluronidase, placental extract and physiotherapy are not beneficial to provide a long-term effect in advanced cases of oral submucous fibrosis   Surgical intervention is required in these cases.  The surgical treatment commonly followed  in our series is the release of bilateral fibrotic bands with Diode Laser.with extraction of both upper lower molars  followed by post op.props for  extensive physiotherapy. We have achieved excellent results in all cases.
Conclusion
In this study, the occurrence of OSMF was higher in the younger age group of 20-29 years. The prevalence of OSMF was more in males than in females with a ratio of 6:1. The number of patients with a paanmasala chewing habit (68.0%) was higher than the number of patients with betel nut (17.4%) or betel quid chewing habits (14.6%). The chewing of paanmasala was associated with earlier presentation of OSMF as compared to betel nut chewing. Significant and direct correlation to the manifestation of OSMF was seen with frequency rather than duration of chewing.

The maximum number of patients (74.3%) as well as most of the paanmasala chewers were in clinical stage II. Although various degrees of epithelial dysplasia were observed, malignant transformation was not seen. There was no correlation between clinical staging to histopathological grading. This observation could be explained by the fact that patients with higher histopathological grading could have had more collagenous bands in the posterior region, which restricted the mouth opening. Chronic inflammatory cell infiltrate was observed in a large number of cases in histopathological grade I but less so in higher histopathological grades, possibly due to a stabilisation of the lesion and a decrease in the levels of proinflammatory mediators.   The follow up examinations after the surgery showed significant improvement in  mouth opening . The key point was extensive physiotherapy to sustain the mouth opening.  There is no doubt that diode laser surgery is very effective and less invasive technique to treat Submucous fibrosis and offers great relief to the terrible state the patients suffer because of this disease .This technique has less morbidity and is suitable for Asian population as it requires less hospital stay and less followup as compared to other surgical methods.
 
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