Evaluation of Cyclosporine A with β-TCP in the Treatment of Human Infra bony Defects - A Randomized Controlled Pilot Study.

Abstract

Cyclosporine A (CsA), an immunosuppressant, is considered a life saver drug in organ transplant cases. It has also been tested in animal and human studies for periodontal applications as it selectively inhibits T lymphocyte proliferation, Interleukin-2 (IL-2) and other cytokine production, without any effect on T suppressor cells, thereby suppressing the cell mediated immunity and suppressing the inflammation. Inflammatory and immunological responses have been found to be decreased and bone formation is found to be increased in immunosuppressed animals. CsA is also supposed to potentiate osseous regeneration due to increase in the bone alkaline phosphatase levels and a direct activating effect on osteoblasts. The present study was aimed at evaluating locally administered low dose of CsA which is potent immunosuppressant along with β-Tricalcium phosphate (β-TCP) in comparison with β TCP alone, in the treatment of human infrabony defects, over a period of six months. Thirty two systemically healthy chronic periodontitis patients with infrabony defects were included in the randomized, controlled, parallel arm study and were allocated into either Group A (n =16), patients treated with β-TCP + CsA (2 mg) or Group B (n =16), patients treated with β-TCP. Clinical parameters [Relative Attachment Level (RAL), Probing Depth (PD), Gingival Recession (GR)] and radiographic parameters were measured at baseline and six months postoperatively. Statistical analysis was done using SPSS version 16 software. Student's paired and independent t-test were used for intra and inter-group analysis. Both Group A and Group B showed statistically significant improvements in clinical and radiographic parameters from base line to six months post-operatively. The Clinical Attachment Level (CAL) gain, Linear Bone Growth (LBG) and Percentage Bone Fill (% BF) were 2.38±1.12 mm, 1.90±1.48 mm and 49.83±29.23 mm in Group A and 2.57±1.22 mm, 2.03±1.16 mm and 62.84±29.70 mm in Group B respectively, inter group comparison showed no statistically significant difference. Both the groups revealed statistically significant improvement in clinical and radiographic parameters and adjunctive use of CsA did not prove beneficial.