Clinical Trial: Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 C

Brief Summary:

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.


Detailed Summary:

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
Sponsor: Government College of Dentistry, Indore

Current Primary Outcome:

  • Mouth opening in centimeters [ Time Frame: Baseline ]
    comparison of pre operative,intra operative,1 week post operative , 2nd week, 3rd week,4th week, 2nd month,3rd month, 6th month post operative mouth opening.
  • Mouth opening in centimeters [ Time Frame: 1week ]
  • Mouth opening in centimeters [ Time Frame: 2week ]
  • Mouth opening in centimeters [ Time Frame: 3week ]
  • Mouth opening in centimeters [ Time Frame: 4 week ]
  • Mouth opening in centimeters [ Time Frame: 2 month ]
  • Mouth opening in centimeters [ Time Frame: 3 month ]
  • Mouth opening in centimeters [ Time Frame: 6 month ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Government College of Dentistry, Indore

Dates:
Date Received: February 16, 2016
Date Started: March 2011
Date Completion:
Last Updated: March 12, 2016
Last Verified: March 2016