Oral Submucous Fibrosis Clinical Trial
Official title:
Evaluation of Change in Mouth Opening in Oral Submucous Fibrosis Patients After Surgical Excision of Fibrous Bands Along With Bilateral Coronoidotomy and Surgical Defect Coverage by Single Stage Extended Nasolabial Flap
Long standing oral submucous fibrosis(OSMF) is associated with involvement
of the oral submucosa and the muscles of mastication leading to difficulty in mouth
opening. Various surgical modalities are mentioned for release but each has its own
limitations.The aim of the study was to evaluate the change in mouth opening in patients of
OSMF after excision of fibrous bands followed by coronoidotomy and surgical defect coverage
by single stage nasolabial flap.
The world of medical science is replete with a plethora of conditions both physiological and
pathological which exhibit manifold symptoms, some of which man has conquered while against
others, he is still waging a relentless battle. In this fast changing world of stress and
cut throat competition, we humans often resort ourselves to tension relieving habits like
alcoholism, smoking, tobacco or betel nut chewing. Apart from the very severe systemic
consequences of these habits, oral cavity is also very adversely affected. Of all the unique
oral afflictions that these habits have on oral cavity of betel quid chewers, Oral Submucous
Fibrosis (OSMF) holds a pivotal position.
OSMF is a distressing condition in which due to limited opening of the oral cavity, the
patient is neither able to consume a normal diet nor maintain proper oral hygiene. OSMF
mostly occurs in Asian countries, including India ,China, Pakistan, Sri Lanka and
Bangladesh, where chewing betel quid (areca nut , tobacco, slaked lime, or other species) is
very popular & accepted as form of tradition in most part of these countries. It is observed
that irritants like betel nuts, tobacco etc. if kept for longer period around the cheek and
swallowed gradually may play a major part in the causation of the disease.
In India, the first mention of this disease in literature dates back to time of 'Sushruta'
as 'Vidari'. However in modern literature 'Schwartz' in 1952 first described it as
"Atrophica idiopathica mucosa oris".
Oral submucous fibrosis is "an insidious, chronic disease affecting any part of the oral
cavity and sometimes the pharynx. Although occasionally preceded by and/or associated with
vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction
followed by a fibroelastic change of the lamina propria, with epithelial atrophy leading to
stiffness of the oral mucosa causing trismus and inability to eat" Usually in this disease
patient has no disabling symptoms in the early phase, but as it progress it causes burning
sensation, difficulty in eating and opening of mouth, that forces patients to report a
clinician with these distressing symptoms. Sharp (1956) has described submucous fibrosis
along with epithelial hyperplasia and mucosal atrophy as a characteristic feature of
abnormal-precancerous oral epithelium and of tissue adjacent to frank oral cancer. OSMF can
transform into oral cancer, and particularly squamous-cell carcinoma, at a rate in the range
of 7% to 13%.
OSMF can occur in any decade of life but is commonly seen in 2nd -4th decade of life.
Various studies have suggested multifactorial origin of the disease with high incidence
associated with consumption of areca nut. Reduction or preferably stoppage of the habit
forms an essential component of the total treatment plan. The mainstay in the treatment of
OSMF is therefore concentrated upon improving mouth opening and relieving the symptoms
either by medicinal or surgical means. The medicinal treatment for mild cases of OSMF
includes steroids, cardiovascular drugs, antioxidants, vitamins and iron supplements.
Topical application of steroids, hyaluronidase, collagenase, and placental extract has
yielded positive results in mild cases but in advanced cases, surgery followed by aggressive
physiotherapy is the only viable treatment which produces satisfactory results.
Excision of the fibrous bands and propping the mouth open to allow secondary
epithelialisation causes rebound fibrosis during healing. Release of fibrous bands and split
thickness skin grafting has a high recurrence from contracture. The survival of full
thickness skin grafts is questionable. The use of island palatal flaps based on the greater
palatine artery as recommended by Khanna et al. has limitations including involvement of the
donor site by fibrosis, limited donor tissue with limited reach of the flap, and the need
for extraction of maxillary second molars to cover the defect with the flap under no
tension. The bilateral tongue flaps cause severe dysphasia, disarticulation, and carry the
risk of postoperative aspiration. They also provide a limited amount of donor tissue as
their reach is inadequate. The stability of a tongue flap and dehiscence are the common
postoperative complications of uncontrolled tongue movements. Apart from this the reported
involvement of the tongue is 38%, which precludes its use for reconstruction. Buccal fat
pads may also be used to cover the defects after excision of the fibrous bands. The
harvesting of the buccal fat pad is simple because access is easy. However, severe atrophy
of buccal fat pads is seen in patients with chronic disease. In addition, the anterior reach
of the buccal fat pad is often inadequate, and the region anterior to the cuspid is required
to be left raw. This raw area heals by secondary intention and subsequently fibrosis,
leading to gradual relapse. Bilateral radial forearm free flaps are hairy, 40% of patients
require secondary debulking procedures, and the facilities for free tissue transfer are not
universally available. Canniff and Harvey recommended temporal myotomy or coronoidectomy to
release severe trismus caused by the atrophic changes in the tendon of temporalis muscle
secondary to the disease.
The use of the nasolabial flap in reconstruction of head and neck defects has proved to be
efficacious and reliable. The versatility of this flap has been attributed to the fact that
there is often abundant non - hair bearing skin in this well vascularized region. Also the
proximity to the defect and achievement of good cosmetic result with preservation of
function and least distortion of anatomy makes it the flap of choice. Therefore, these
advantages of 'extended single stage nasolabial flap' in the treatment of OSMF led us to
carry out this study for "Evaluation of change in mouth opening in centimeters in oral
submucous fibrosis patients after surgical excision of fibrous bands along with bilateral
coronoidotomy & surgical defect coverage by single stage nasolabial flap". Mouth opening in
centimeters was recorded pre operatively(base line),to 1 week,2 week,3 week,4 week, 2nd
month,3rd month and 6 month post operatively and the change was recorded.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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