Enamel matrix derivative in the treatment of human intrabony osseous defects

Background: There is limited information available from clinical trials regarding the performance of enamel matrix derivative (EMD) in the treatment of periodontal intrabony defects. This randomized, double-blind, placebo-controlled, split-mouth study was designed to compare the clinical and radiographical effects of EMD treatment to that of placebo-controlled treatment for intrabony defects. Methods: Sixteen patients were included, each of whom had 1 or 2 pairs of intrabony defects located contralaterally in the same arch. Thirty-six intrabony defects were randomly assigned treatment with flap surgery plus EMD or flap surgery plus placebo. At baseline and at the 12-month follow-up evaluation visit, clinical and radiographic measurements were determined. Data were statistically analyzed using the Wilcoxon-signed rank test (α = 0.05). 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). Probing 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 clinical 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 (20.2 ± 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. J Periodontol 2000;71:1821-1828.