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ORIGINAL ARTICLE
Year : 2014  |  Volume : 26  |  Issue : 4  |  Page : 369-373

Randomized controlled trial to evaluate the efficacy of oral lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia


1 Department of Oral Medicine and Radiology, M.A. Rangoonwala College of Dental Sciences and Research Centre, Pune, India
2 Department of Oral Medicine and Radiology, Government Dental College, Mumbai, India
3 Department of Oral Medicine and Radiology, Terna Dental College and Hospital, Navi Mumbai, India
4 Department of Periodontology, Saraswati Dhanwantari Dental College, Parbhani, Maharashtra, India
5 Department of Oral and Maxillofacial Surgery, Saraswati Dhanwantari Dental College, Parbhani, Maharashtra, India

Correspondence Address:
Jyotsna Sandeep Patel
29/D, Rameshwer Apartments, Morar Road, Mulund (West), Mumbai - 400 080, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-1363.155630

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Aims and Objectives: A randomized controlled study was carried out to evaluate the efficacy of lycopene in combination with vitamin E and selenium in the treatment of oral leukoplakia in patients visiting the Government Dental College and Hospital, Mumbai. Materials and Methods: Forty-one patients of leukoplakia were randomly categorized (irrespective of size and severity of the lesions) in two groups: Group A and B. Group A consisting of 21 patients were administered combination of lycopene (3 mg), vitamin E (200 I.U.) and selenium (100 mcg) twice daily and group B consisting of 20 patients were given placebo capsules once daily for a period of 3 months. Post-treatment follow-up period was 3-4 months. The product used in the study was LYC-O-MATO soft gels, manufactured by Mano pharmaceuticals, Chennai, India. The treatment outcome was evaluated both clinically and histologically and the results were statistically evaluated using Student's unpaired 't' test. Results: The results showed that the patients receiving lycopene in combination with vitamin E and selenium have statistically significant improvements both clinically and histologically as compared to those receiving placebo and with no side effects. Conclusion: The study results proved the efficacy and safety of lycopene along with selenium and vitamin E in the management of oral leukoplakia.


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