Enamel matrix derivative in the treatment of human intrabony osseous defects

Background: There is limited information available from clinical trials reg arding the performance of enamel matrix derivative (EMD) in the treatment o f periodontal intrabony defects. This randomized, double-blind, placebo-con trolled, split-mouth study was designed to compare the clinical and radiogr aphical effects of EMD treatment to that of placebo-controlled treatment fo r intrabony defects. Methods: Sixteen patients were included, each of whom had 1 or 2 pairs of i ntrabony defects located contralaterally in the same arch. Thirty-six intra bony defects were randomly assigned treatment with flap surgery plus EMD or flap surgery plus placebo. At baseline and at the 12-month follow-up evalu ation visit, clinical and radiographic measurements were determined. Data w ere statistically analyzed using the Wilcoxon-signed rank test (alpha = 0.0 5). Results: At the 12-month visit, bleeding on probing for the EMD group was 0 ,11 +/- 0.32 compared to the placebo group, 0.61 +/- 0.50 (P < 0.05). Probi ng depth reduction was greater in the EMD group (3.00 +/- 0.97 mm) compared to the placebo group (2.22 +/- 0.81 mm) (P < 0,05). Mean values for clinic al attachment gain in the EMD and the placebo groups were 1.72 +/- 1.07 mm and 0.83 +/- 0.86 mm, respectively (P < 0.05), Vertical relative attachment gain was 38.5 +/- 22.6% in the EMD group and 21,4 +/- 25.2% in the placebo group (P < 0.05). Radiographic bone density gain was greater in the EMD (2 0.2 +/- 16.6%) compared to the placebo group (-3.94 +/- 23.3%) (P < 0.01). Conclusions: Treatment with flap surgery and EMD, compared to flap surgery with placebo, produced a significantly more favorable clinical improvement in intrabony periodontal defects.