Evaluation of the effect of newer antioxidant lycopene in the treatment of oral submucous fibrosis

Indian J Dent Res. 2012 Jul-Aug;23(4):524-8. doi: 10.4103/0970-9290.104964.


Background and objective: Oral submucous fibrosis (OSMF) is a well-known premalignant condition encountered in Indian population. Although the disease is advancing rapidly, its reliable treatment modality for its various stages has not yet evolved. The aim of the present study is to compare the effect of newer antioxidant lycopene with a placebo in conjunction with the cessation of causative habit in the treatment of OSMF.

Materials and methods: The study group included 92 patients with OSMF. The OSMF diagnosis was established through a composite of accepted clinical and histopathological characteristics. Out of 92, 46 patients were given lycopene and remaining 46 were on placebo drug. Lycopene group patients received 8 mg Lycored TM per day in two divided doses of 4 mg each, while placebo group patients received placebo tablet twice a day. Patients were examined for changes in mouth opening and other clinical symptoms of OSMF during three months and were followed up for next two months.

Results: Lycopene was found to be significantly efficacious in the amelioration of signs and symptoms of OSMF. It was effective in reducing the objective signs of OSMF as demonstrated by the improved maximal mouth opening, percentage of which was 69.56%(P<0.05).

Interpretation and conclusion: Reactive oxygen compounds or free radicals have been implicated as one of the major harmful factors for premalignant and malignant conditions. Present study concludes that lycopene, a newer antioxidant, appears to be a very promising drug in the management of OSMF.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Antioxidants / therapeutic use*
  • Biopsy, Needle
  • Carotenoids / therapeutic use*
  • Collagen
  • Connective Tissue / drug effects
  • Connective Tissue / pathology
  • Epithelium / drug effects
  • Epithelium / pathology
  • Erythema / drug therapy
  • Erythema / pathology
  • Female
  • Follow-Up Studies
  • Humans
  • Lycopene
  • Male
  • Middle Aged
  • Oral Submucous Fibrosis / drug therapy*
  • Oral Submucous Fibrosis / pathology
  • Oral Ulcer / drug therapy
  • Oral Ulcer / pathology
  • Placebos
  • Range of Motion, Articular / drug effects
  • Single-Blind Method
  • Treatment Outcome
  • Young Adult


  • Antioxidants
  • Placebos
  • Carotenoids
  • Collagen
  • Lycopene