Comparison of effectiveness of Calendula officinalis extract with Lycopene gel for treatment of tobacco induced Homogenous Leukoplakia – A Randomised clinical Trial

Oral Leukoplakia is the most common potentially malignant disorder of the oral mucosa. It has been reported that between 16% and 62% of oral squamous cell carcinomas are associated with oral Leukoplakia. Early diagnosis and treatment of these potentially malignant disorders is required to prevent their progression to malignancy.Current treatment modalities include cessation of tobacco chewing habit and Lycopene as a powerful antioxidant.Many herbal medicines have been tried in management of oral diseases including premalignancies. Calendula Officinalis is one among the herbal medicines which has the potential antioxidant property.Calendula officinalis also known as pot marigold is an annual herb belonging to family Asteraceae.Research has shown that Calendula officinalis contains flavonoids,polyphenols,lutein,flavoxanthin,lycopene,auroxanthin,betacarotene which possesses antioxidant property.

The Aim of this research work is to assess the efficacy of Calendula Officinalis gel as cost effective treatment modality in comparison to Lycopene gel in treatment of Leukoplakia.

Sixty patients of either sex with clinically diagnosed and histopathologically confirmed cases of homogenous leukolplakia were selected reporting to department of Oral medicine and Radiology,KLE.Patients with potentially malignant disorders other than homogenous leukoplakia,any past history of major illness within a period of 6 months,allergy to Asterceae family and lycopene were excluded.Patients included 60 clinically and histopathologically confirmed cases of homogenous leukoplakia based on the which were randomly divided into Group I and Group II with 30 patients each.Group I patients were dispensed Calendula Officinalis extract gel whereas Group II patients were given Lycopene gel.Tobacco cessation counseling was done for all patients at the very first appointment and they were instructed to apply the gel thrice daily after breakfast,lunch and dinner. The therapy was instituted for 1 month to assess the change in size of lesion at the baseline and post treatment(at the end of 1 month).The data obtained was statistically analyzed by paired t test and unpaired t test.

The results revealed a statistically significant difference in both Group I and Group II when the pre and post treatment results were compared in the same group.The intergroup comparison for the evaluation of reduction in size of the lesion did not reveal statistically significant results.Hence the study concluded that Calendula Officinalis extract gel can be effectively used as an alternative to conventional treatment modality.