Comparative Effect of Nigella Sativa and Conventional Management for OSMF

Study Overview
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Brief Summary
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Oral submucous fibrosis (OSMF) is a potentially malignant condition mainly characterized by inflammation and fibrosis of the submucosal tissues leading to marked rigidity and reduced opening of the jaws. OSMF has a multifactorial etiology but areca nut consumption is considered to be the most consistent factor in its pathogenesis. There is no definitive treatment available for treating OSMF. Conventional management involves physiotherapy exercises and treating the disease with certain medications such as steroids and homeopathic medications.

Detailed Description
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OSMF is a chronic insidious disorder of the oral cavity which has a great potential to turn malignant. The clinical manifestations of OSMF comprise of white, marble-like appearance of the oral mucosa with loss of flexibility and formation of palpable fibrous bands extending from the anterior to the posterior region of the oral cavity.Other features include burning sensation on taking spicy food, loss of papillae of the tongue, loss of natural pigmentation of the lips and restricted mouth opening. There is no definitive treatment available for OSMF due to its complex etiology. The most essential component in the management of OSMF is the discontinuation of the habit of areca nut chewing by the patient followed by conservative or surgical treatment. Currently, steroids are the most commonly used drug group in managing OSMF because of their ability to reduce the inflammatory process and increasing the apoptosis of inflammatory cells thereby decreasing fibrosis. However, they are not very useful in reversing the pathology and restoring mucosal elasticity and can cause mucosal thinning with long term use ultimately resulting in worsening of the symptoms of the disease. Many in- vitro and in- vivo studies have been conducted to establish the anti neoplastic, anti inflammatory, immunomodulatory, antihypertensive, antimicrobial, anti-parasitic, antioxidant and hypoglycemic properties of N.sativa oil. Among all the constituents of Nigella sativa, Thymoquinone (Tq) is the most pharmacologically active constituent responsible for most of its properties. Nigella sativa has been used widely in different food preparations in the form of a flavoring agent or a spice. It is also recognized as 'safe' in the inventory of United States Food and Drug administration.

Official Title
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Comparison of Nigella Sativa Oil With Conventional Management on Clinical Outcomes in Oral Submucous Fibrosis

Conditions
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Oral Submucous Fibrosis

Intervention / Treatment
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* Dietary Supplement: Nigella sativa oil
* Drug: Betamethasone Valerate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the age of 18 years and above Patients clinically diagnosed with Oral submucous fibrosis Patients who have not received any treatment for Oral submucous fibrosis in the last three months. Patients who are willing to quit the habit of eating pan, gutka and areca nut Patients who are willing to attend the follow up visits Exclusion Criteria: Patients who are less than 18 years of age Patients who are already using pain medications, corticosteroids or immunosuppressive drugs in any other form Patients with a history of malignancy Patients presenting with oral lesions other than Oral submucous fibrosis (OSMF) Patients who are allergic to the drug material used in the clinical trial Patients who will not give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid group<br>Participants in group 1 will be given corticosteroid lotion (Betamethasone valerate 0.1%) and will be advised to apply it topically (0.5 ml) on the buccal mucosa thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side). | Drug: Betamethasone Valerate<br>* it is a conventionally used drug for treating OSMF<br>* Other names: Corticosteroid;|
| Experimental: Nigella Sativa oil group<br>Group 2 will be given commercially available, cold pressed N.sativa (Black seed) oil and will be advised to apply it topically over the buccal mucosa (1 ml) thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side). | Dietary Supplement: Nigella sativa oil<br>* Using N.sativa oil as an alternative to conventional management will help us to find a treatment option which is non-invasive, cost effective, inexpensive, easy available and belongs to a natural source with almost no side effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed using visual analogue scale (VAS) | Pain will be measured using VAS. This scale usually present as a 100-mm horizontal line on which the pain intensity experienced by the patient will be represented by a point between the extremes of no pain at all and worst pain imaginable. | 6 months | 
| Inter-incisal mouth opening (IMO) assessed using vernier caliper | Interincisal mouth opening will be calculated by measuring the distance between the mesioincisal angles of the maxillary central incisor and the mandibular central incisor with the help of a vernier calliper. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cheek Flexibility assessed following the method of Mathur and Jha (1993) | A line will be drawn from the tragus of the ear to the angle of the mouth and then two reference points will be marked on both the cheeks at 1/3rd the distance from the angle of the mouth on the line drawn previously. After marking these reference points, the patient will be asked to blow his cheek and the distance will be measured between the two points. Then the patient will be instructed to relax his cheeks and the distance will be measured again. The difference between the two values will give the value for cheek flexibility. | 6 months | 
| Tongue protrusion | Tongue protrusion will be recorded by measuring the distance between the tip of the tongue and the mesioincisal angle of the upper central incisor using steel ruler. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSMF