Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is
associated with both significant morbidity (including burning sensation and reduced oral
opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has
largely been symptomatic and is associated with high recurrence rate. Aloevera has
immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic
activities. All such properties of Aloevera suggest the possibility of its use in the
management of oral submucous fibrosis.
In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2
groups (Group A & B). Group A patients were instructed to drink 30ml of aloe vera juice twice
daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion 3-4
times daily for 3 months. Group B patients were given intralesional injections of 1.5ml
Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also
prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg,
Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of the
capsule) for 3 months. Patients were assessed for burning sensation, interincisal
mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.
Phase:
Phase 3
Details
Lead Sponsor:
The Oxford Dental College, Hospital and Research Center, Bangalore, India