Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study

NCT ID: NCT02714543

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-11-30

Brief 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.

Conditions

Oral SubMucous Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aloevera group

aloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months

Group Type: EXPERIMENTAL

aloevera juice

Intervention Type: DRUG

aloevera juice to drink twice daily for 3 months.

aloevera gel

Intervention Type: DRUG

aloevera gel one scoop to be applied 3-4 times daily for 3 months

steroid group

intralesional injection of hydrocortisone 100mg and injection hyaluronic acid 1500IU once a week for 6 weeks with Capsules SM Fibro once daily for 3 months.

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

intralesional injection of hydrocortisone 100mg once a week for 6 weeks

Hyaluronic Acid

Intervention Type: DRUG

injection hyaluronic acid 1500IU once a week for 6 weeks

antioxidant

Intervention Type: DRUG

Capsules SM Fibro (antioxidants) once daily for 3 months.

Interventions

aloevera juice

aloevera juice to drink twice daily for 3 months.

Intervention Type: DRUG

Hydrocortisone

intralesional injection of hydrocortisone 100mg once a week for 6 weeks

Intervention Type: DRUG

Hyaluronic Acid

injection hyaluronic acid 1500IU once a week for 6 weeks

Intervention Type: DRUG

antioxidant

Capsules SM Fibro (antioxidants) once daily for 3 months.

Intervention Type: DRUG

aloevera gel

aloevera gel one scoop to be applied 3-4 times daily for 3 months

Intervention Type: DRUG

Other Intervention Names

Capsule SM Fibro

Eligibility Criteria

Inclusion Criteria

1. Clinically diagnosed stage 2 OSMF patients.

2. Patients who were ready to quit the habit and accept regular follow up protocol.

Exclusion Criteria

1. Patients with stage 1 & 3 OSMF.

2. Patients with history of hypersensitivity to aloevera.

3. Pregnant women & lactating mothers.

4. Patients who had undergone any other treatment for OSMF.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Oxford Dental College, Hospital and Research Center, Bangalore, India

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anuradha Pai

Professor and Head, Dept of oral medicine and radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OxfordDC

Identifier Type: -

Identifier Source: org_study_id