Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract

The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN at 1 comparable site. In total, 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery, 56 other samples were taken after one treatment with EMDOGAIN, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of postsurgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months postsurgery, and this difference had increased further at the 3 year follow-up. The 2.5-3 mm increase in attachment and bone level after treatment with EMDOGAIN was of the same magnitude as seen in the studies with split-mouth design aiming for test of effectiveness of EMDOGAIN.

Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects

“…Based on the previous study, (12)(13)(14)(15) it was assumed that the size of the EMD-induced effect on linear alveolar bone growth 36 weeks after administration was 0.81 mm. The estimated size of the rhFGF-2-induced effect from the pooled data in Study A and previous studies (9,10) was about 1.05 mm.…”

Emdogain® in carcinogenesis: a systematic review of in vitro studies

“…Despite the lack of studies and the fact that EMD is known to have growth factor-like effects on different cell lines, EMD is said to be clinically safe (8)(9)(10). However, assessments of clinical safety have been limited to evaluations of the capability of porcine enamel proteins to induce immunological reactions or local postoperative symptoms, such as pain or sensitivity in the teeth involved, which have been studied both in vitro and in vivo (8)(9)(10)(11)(12)(13). There is abundant evidence regarding the effects of EMD on periodontal tissues, including its stimulation of periodontal and gingival fibroblast cell migration and proliferation.…”

Periodontal regeneration in intrabony defects after application of enamel matrix proteins with guided tissue regeneration: An experimental study in dogs

“…The apical border of the notch (N) to the cewhich supports the hypothesis on clinical usefulness of EMP. The safety and effectiveness of EMP for improving the repair of periodontal bone defects have been noted in humans and other animals (17,23), and a histological study reported that the true periodontal regeneration ability was maintained (12). The adjuvant use of EMP in regeneration therapy aimed at the formation of cementum, alveolar bone and periodontal membrane structure is expected.…”