Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: A randomized controlled trial

Abstract

Introduction. Emdogain® represents an extracellular matrix derivative that controls and promotes periodontal regeneration. Several studies have demonstrated that the treatment of periodontal defects with Emdogain® leads to improvements in clinical parameters. However, long-time clinical trials establishing clinical usefulness of Emdogain® are scarce. Therefore, the present randomized split mouth, controlled study was undertaken to evaluate the effectiveness of Emdogain® as an adjunct to open flap debridement for the treatment of intra-bony defects over a period of 5 years. Materials and methods. The study population consisted of 15 chronic periodontitis patients with bilateral interproximal osseous defects. The test group was treated by open flap debridement with EDTA 24% (PrefGel®) followed by enamel matrix derivative (Emdogain®). The control group was treated by open flap debridement with EDTA 24% (PrefGel®). Results. After 1 and 5 years, both the test and control groups showed significant mean PPD reduction. A greater reduction in mean Probing Pocket Depth (PPD) was observed in the test group (3.84 ± 1.05) as compared to the control group (1.92 ± 0.35). The mean Clinical Attachment Level (CAL) gain of 3.18 ± 0.87 mm was observed in the test group, while the control group displayed mean CAL gain of 1.60 ± 0.54 mm. The observed differences were found to be statistically significant in both the groups (p < 0.05). Percentage bone fill was significantly increased at 12 months post-surgery in test group (66.66 ± 7.8%) as compared to control group (31.71 ± 4.1%). Conclusion. The treatment with Emdogain resulted in a significantly higher CAL gain and PPD reduction in comparison with OFD and PrefGel®.