6.1] Need for the study

Oral sub mucous fibrosis[OSMF] is a chronic, progressive, scarring, high risk precancerous condition of the oral mucosa seen primarily in the Indian subcontinent .The condition is  characterised by mucosal rigidity of varied caused by fibroelastic hyperplasia and modification of the superficial connective tissue.

Etiological factors for this are betel quid or paan.

Its clinical features include Trismus, Stomatopyrosis, Vesicles, petechiae, melanosis, xerostomia,etc.Treatment options depends on the grade of the condition/mouth opening.

Patients with mild OSMF can be treated with intra-lesional corticosteroids injections.

Patient with moderate to severe  OSMF need surgical treatment for correction.

Surgical treatment is required when the mouth opening is below2.5cm

The most common flap used is the nasolabial flap for reconstruction of buccal wound. The advantages of nasolabial flaps are reliable and rich vascularity, versatility of design, proximity to the defect, ease of flap elevation, and supple skin, thus aiding in increasing mouth opening. 

The major disadvantages of this golden flap is the extra oral hypertrophic scar at the donor site that hampers the aesthetic of the patient, other disadvantages are necrosis of the flap at the tip, temporary widening of the oral commissure and painduring opening of mouth. Therefore, there exist a need for a treatment with better aesthetics and less pain.Submental flap is being used in reconstruction of various head and neck defects.As stated in a article by Gadre K et al in their case report, the bilateral submental flap shows amazing results in such OSMF.Thus, the purpose of this study is to compare the efficacy of nasolabial flap and the bilateral subnmental flap for reconstruction in OSMF surgery.

6.2] Review of literature:

1. Lee J.T. et al in the year 2007, conducted a study in 10 histologically confirmed OSMF patients, using bipaddled radial forearm flap for the correction of bilateral buccal defect. The author states that 1 out of 9 developed thrombosis 24hr post surgery, 2 patients needed flap revision due to bulkiness, relapse was seen in 3 patients due to failure of exercise post operatively. There was an average of 7.3 mm decrease in the size of the mouth opening. Major disadvantages is microvascular surgeries are required.

1. Borle R.M. et al in the year 2008, conducted a study where 47 patients with histologically confirmed oral sub mucous fibrosis took part in evaluation of extended nasolabial flaps and coronoidectomy. The author states that the patients were treated by bilateral release of fibrous bands, coronoidectomy and extended grafting with nasolabial flap, showed improved mouth opening but it had some disadvantages like partial flap necrosis particularly at the tips, temporary widening of the oral commissure, etc. but the major disadvantage is the extra oral scar.

1. Rai A. et al in the year 2012, conducted a study to compare buccal fat pad(BFP) and the nasolabial flap(NLF)  in 20 OSMF patients. As a result In patients treated with  BFP showed less mean mouth opening to NLF and also fish mouth was encountered lately in BFP patients and atrophy of buccal fat pads in patients with chronic disease. 4) Gadre Ket al in the year 2017 conducted a study in 20 patients , using bilateral submental flap in oral submucous fibrosis patients. The author states that Submental flap has a reliable vascular supply, is simple to harvest, has favorable physical characteristics (pliability, mobility, color, texture, and volume) with low donor site morbidity, and can be used as a cutaneous, fasciocutaneous, musculocutaneous, or osseocutaneous flap. The donor site scar is well hidden in the shadow of the mandible and provide tightening of the submental skin.

   
   

   5) Zenga J. et al in the year 2019, conducted a single institutional case series with chart review, in which they used the submental flap in head and neck defects. The objective of this report is to describe a technical modification to the submental flap harvest which increases efficiency and reliability.All flaps included the mylohyoid muscle which was delineated with manual blunt dissection. Reconstructive indications included oral cavity and oropharyngeal wounds as well as facial cutaneous and lateral skullbase defects. There were no flap-related complications. Manual blunt dissection of the mylohyoid muscle and its inclusion in the submental island flap increases efficiency and reliability. .1] Source of Data 

   Type of study-  Clinical Comparative Study

   In-vitro/in-vivo/survey- In-vivo study.

   
   

   Source from where the cases, patients, subjects or study material will be selected: Department of Oral & Maxillofacial Surgery, Dr. D.Y. Patil Dental College & Hospital, Pimpri, Pune.

   
   

   Name and place where the study will be conducted: Department of Oral and Maxillofacial Surgery, Dr D Y Patil Dental College & Hospital, Pimpri,Pune. ; Dr D.Y. Patil Medical Hospital,Pimpri,Pune.

   
   

   
   

   7.2] Method of data Collection

   
   

   Sampling technique used –   Convenience Sampling with sequential allocation.

   
   

   Sample size – N= 08 Oral Submucous Fibrosis

   
   

   Size of each group or sub-group-

   
   

   Sample size – N = 08 Oral Submucous Fibrosis

   
   

   Group A – (n= 04) submental falp

   
   

   Group B – (n= 04) nasolabial flap Descirbe how the study will be done in a step-wise chronological sequence:

   
   

   Training and calibration of operator will be conducted prior to starting the study

   
   

   Detailed case history will be taken for all the participants.

   
   

   Sequential allocation of the patients will be done to each group

   
   

   Age,gender,csae matching will be done

   
   

   Patient will be posted for surgery under general anaesthesia

   Release of all the intraoral fibrotic tissue from mouth angle to the posterior pharyngeal wall.

   Removal of all 3rd molars will be done.

   Coronoidoctomy will be done either bilaterally/unilaterally as per requirement reconstruction will be done either with bilateral nasolabial flap/submental flap as per group allocation. 

   Suturing of the flap will be done intra orally 

   Extraoral closure of the wound will be done 

   The following parameters will be assed at the time of surgery 

   Time taken for the surgery 

   Adequacy of the flap 

   Post operative pain assessment on VAS 

   Mouth opening(in mm) will be assessed at 3 points:

                                              Immediately :

                                                  6th month :

                                                 12th month:

   
   

   
   

   
   

   Duration of study: one year and half year

   
   

   Method of data analysis:

   Repeated measure ANOVA

   
   

   
   

   Does the study require any investigation or intervention to be made on patients,any human or animals?

   -YES

   
   

   Yes, briefly describe: Correction of oral Sub mucous fibrosis with Submental Flap and Nasolabial Flap