Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study
Condition: Oral SubMucous Fibrosis
MeSH terms: Oral Submucous Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Material and Methods The present study was conducted in the Department of Oral Medicine and
      Radiology at The Oxford Dental College and Hospital, Bangalore, India between November 2013
      to August 2015. Approval from the institutional ethical committee was obtained for the study.
      Patients with Oral SubMucous Fibrosis (Stage 2 according to Pindborg) were enrolled in the
      study. Pregnant women, lactating mothers, patients with known history of hypersensitivity to
      aloevera and those who had received prior treatment for OSMF were excluded. 74 patients who
      were ready to quit the habit and accept regular follow up treatment protocol were included in
      the study. An informed consent was obtained from all the patients after the nature of the
      study and its procedures were explained. A thorough clinical examination was done and the
      following parameters were measured and recorded by an independent examiner.

        1. The intensity of burning sensation was recorded using a Numerical Rating Visual Analogue
           Scale.

        2. The interincisal mouth opening was measured using a metal scale and divider from the
           mesioincisal angle of upper central incisor to the mesioincisal angle of lower central
           incisor and recorded in millimeters.

        3. Cheek flexibility (CF) was measured according to the method described by Bailoor and
           Nagesh. Two points were marked, one on each side of the face at 1/3rd the distance from
           angle of the mouth on a line joining the tragus of the ear and the angle of the mouth.
           The distance measured between these two points was V2. The subject was asked to blow his
           cheek fully and the distance measured between the same two points was V1. CF=V2-V1.

        4. Tongue protrusion was assessed from normal mesioincisal angle of upper central incisor
           to the tip of the tongue when maximally extended with mouth wide open.

      The patients were randomly divided into 2 groups (Group A & B). Group A patients were given
      pure aloevera gel and pure aloevera juice (Processed and manufactured by Hemant Sai, Sun
      Vision Company, Neel RLI Pvt Ltd). They were instructed to drink 30ml of aloevera juice twice
      daily before food and to apply 5mg (approx 1 scoop) of aloevera gel over the lesion 3 times
      per day for 3 months. Group B patients were given intralesional injections of Hydrocortisone
      acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also prescribed Cap
      SM Fibro twice daily for 3 months. Same baseline parameters were measured and recorded at an
      interval of 1, 2 & 3 months by the same examiner who measured the baseline values and was
      unaware of the treatment received by the study subjects.
    

Intervention name(s): aloevera juice; Hydrocortisone; Hyaluronic Acid; antioxidant; aloevera gel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): aloevera juice to drink twice daily for 3 months.; intralesional injection of hydrocortisone 100mg once a week for 6 weeks; injection hyaluronic acid 1500IU once a week for 6 weeks; Capsules SM Fibro (antioxidants) once daily for 3 months.; aloevera gel one scoop to be applied 3-4 times daily for 3 months
Other intervention name(s): Capsule SM Fibro
Intervention MeSH terms: Hydrocortisone; Hyaluronic Acid; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: OSMF; Aloevera; Hydrocortisone; Hyaluronidase