Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02714543
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Anuradha Pai, The Oxford Dental College, Hospital and Research Center, Bangalore, India

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.


Condition or disease Intervention/treatment Phase
Oral SubMucous Fibrosis Drug: aloevera juice Drug: Hydrocortisone Drug: Hyaluronic Acid Drug: antioxidant Drug: aloevera gel Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : November 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aloevera group
aloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months
Drug: aloevera juice
aloevera juice to drink twice daily for 3 months.

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

Active Comparator: 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.
Drug: Hydrocortisone
intralesional injection of hydrocortisone 100mg once a week for 6 weeks

Drug: Hyaluronic Acid
injection hyaluronic acid 1500IU once a week for 6 weeks

Drug: antioxidant
Capsules SM Fibro (antioxidants) once daily for 3 months.
Other Name: Capsule SM Fibro




Primary Outcome Measures :
  1. burning sensation [ Time Frame: 3 months ]
    Visual analogue scale

  2. mouth opening [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    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. measured in milimeters

  4. tongue protrusion [ Time Frame: 3 months ]
    from mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open. measured in milimeters



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Layout table for additonal information
Responsible Party: Dr. Anuradha Pai, Professor and Head, Dept of oral medicine and radiology, The Oxford Dental College, Hospital and Research Center, Bangalore, India
ClinicalTrials.gov Identifier: NCT02714543     History of Changes
Other Study ID Numbers: OxfordDC
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Keywords provided by Dr. Anuradha Pai, The Oxford Dental College, Hospital and Research Center, Bangalore, India:
OSMF
Aloevera
Hydrocortisone
Hyaluronidase

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrosis
Oral Submucous Fibrosis
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Antioxidants
Hyaluronic Acid
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements