Evaluating the therapeutic efficacy of Moringa oleifera leaf extract oral gel versus Retino-A cream in oral homogenous leukoplakia. A double blinded randomized controlled trial.

Aim of study

Evaluating the therapeutic efficacy of Moringa oleifera leaf extract oral gel 2 percentage versus Retino A cream 0.1 percentage in the management of homogenous oral leukoplakia.

Objectives of study

1.To evaluate the therapeutic efficacy of Moringa oleifera leaf extract oral gel 2 percentage in reducing the size of lesions in patients with homogeneous oral leukoplakia.

2.To assess the therapeutic efficacy of Retino A cream 0.1 percentage in reducing the size of lesions in patients with homogeneous oral leukoplakia.

3.To compare the efficacy of Moringa Oleifera leaf extract oral gel 2 percentage and Retino A cream 0.1 percentage in reducing lesion size in patients with homogenous oral leukoplakia.

Preparation of Moringa oleifera leaf extract

Moringa oleifera leaves are harvested from the Moringa oleifera tree.Then the collected leaves should be washed with distilled water and shade dried for 4 to 5 days. Then the dried leaves are coarsely powdered in the grinder. Extraction of leaves will be done by maceration procedure using a hydroalcoholic method using 70 to 30 ethanol to distilled water. The leaves are to be transferred into a flask dipped in 70 percentage aqueous ethanolic solution for 72 hours in a shaker at 75 rpm and room temperature and ought to extraction repeatedly. Whatmans filter paper no.42 should be used to filter the solution. The obtained filtrate is then transferred to a crucible and dried over a water bath at 40 degreeC. The dry content obtained has to be weighed on the weighing machine. The extract obtained should be stored at 2 to 8 degreeC temperature.

Preparation of Moringa oleifera leaf extract gel

The prepared leaf extract is subsequently treated with Carbopol 940 as a gelling agent. 2 percentage of the gel is prepared by adding 2gm of extract per 100 ml of distilled water. Later TEA Triethanolamine is added to enhance the gelling property. Methyl and ethyl paraben are to be added which are used as preservatives. The obtained gel will be stored in a sterile condition below 8 degreeC of temperature.

Methodology

Each subject in group A will be given freshly prepared Moringa oleifera leaf extract oral gel 2 percentage and subjects in group B will be given commercially available Retino A cream 0.1 percentage. All the subjects will be instructed to apply topically over the lesion area 3 times a day and they will be asked to refrain from eating drinking and rinsing for at least 30 minutes after the application. They will also be informed about the possible allergic reactions and instructed to terminate the use of the drug in the event of any adverse reaction and to report immediately. All the subjects will be reviewed periodically at an interval of every 2 weeks for period of 2 months for the reduction in size of the lesion. All the collected data will be subjected to statistical analysis.

Statistical analysis

1.Descriptive statisticsTo calculate the means and standard deviation of all the parameters or variables in each group.

2.Paired t test for intra group comparison.

3.Independent t test for inter group comparison.