A Phase 3 interventional study of aloevera juice and Hydrocortisone in Oral SubMucous Fibrosis, sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India. Completed. Open to participants aged 17 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-03-21.
Sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India · Phase 3, Interventional, and Treatment
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.
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.
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.
3,256 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's enrollment of 74 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →The Oxford Dental College, Hospital and Research Center, Bangalore, India is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
aloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months
Drug: aloevera juice · Drug: aloevera gel
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 · Drug: Hyaluronic Acid · Drug: antioxidant
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.
Also known as: Capsule SM Fibro
aloevera gel one scoop to be applied 3-4 times daily for 3 months
burning sensation
Visual analogue scale
Time frame: 3 months
mouth opening
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
Time frame: 3 months
cheek flexibility
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
Time frame: 3 months
tongue protrusion
from mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open. measured in milimeters
Time frame: 3 months
No study locations are listed for this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oral Submucous Fibrosis
The Oxford Dental College, Hospital and Research Center, Bangalore, India