Efficacy of Submental flap and Nasolabial flap in Oral Submucous Fibrosis
- Conditions
- INDIVIDUALS CLINICALLY DIAGNOSED WITH ORAL SUBMUCOUS FIBROSIS
- Registration Number
- CTRI/2023/04/051872
- Lead Sponsor
- Dr D Y Patil Dental College and Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 8
- 1)Grade 2 oral sub-mucous fibrosis with mouth opening of less than 25mm.
- 2)Stoppage of habit for 3 months.
- 3)Patient willing to undergo surgery.
- 1)Keloid scar present anywhere in the body.
- 2)Systemic diseases that hamper the wound healing like diabetes mellitus, 3)Immunocompromised conditions, steroid treatment, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Mouth opening Immediate | 6 month follow up | 12 month follow up 2)Time taken for surgery Immediate | 6 month follow up | 12 month follow up 3)Adequacy of the flap Immediate | 6 month follow up | 12 month follow up 4)Postoperative pain assessment on VAS Immediate | 6 month follow up | 12 month follow up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of oral and maxiilofacial surgery,
🇮🇳Pune, MAHARASHTRA, India
Department of oral and maxiilofacial surgery,🇮🇳Pune, MAHARASHTRA, IndiaDr Tushar BhosalePrincipal investigator8308661411drtusharbhosale@gmail.com