Efficacy of lycopene in the management of oral submucous fibrosis

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):207-13. doi: 10.1016/j.tripleo.2006.07.011. Epub 2006 Oct 24.


Objectives: To evaluate the efficacy of oral lycopene therapy in patients with oral submucous fibrosis and to compare these effects with a placebo.

Study design: Fifty-eight patients with oral submucous fibrosis formed the population for the study and were randomly divided into 3 groups, evaluated weekly over a 2-month period. Patients of group A (n = 21) received 16 mg of lycopene, those of group B (n = 19) received 16 mg of lycopene along with biweekly intralesional steroid injections, and those of group C (n = 18) were given a placebo. Paired and unpaired t tests were used for statistical evaluation.

Results: Mouth-opening values for the patients showed an average increase of 3.4 mm, 4.6 mm, and 0.0 mm for patients in groups A, B, and C, respectively. These values were statistically found to be highly significant.

Conclusions: The observed effects suggest that lycopene can and should be used as a first line of therapy in the initial management of oral submucous fibrosis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Inflammatory Agents / therapeutic use
  • Antioxidants / therapeutic use*
  • Areca / adverse effects
  • Betamethasone / therapeutic use
  • Carotenoids / therapeutic use*
  • Humans
  • Lycopene
  • Male
  • Middle Aged
  • Oral Submucous Fibrosis / drug therapy*
  • Range of Motion, Articular


  • Anti-Inflammatory Agents
  • Antioxidants
  • Carotenoids
  • Betamethasone
  • Lycopene