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 I 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 post-surgical 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 post surgery. 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 lest of effectiveness of EMDOGAIN®.     

Conceptual problems in establishing the critical concentration of cadmium in human kidney cortex

The definition of the "critical concentration" for cadmium is compared with the concepts used to establish this measure in some recent publications. The term has not been clearly defined on a population basis and this has given rise to certain confusion. Different groups of investigators therefore have arrived at different estimates of the "critical concentration" for cadmium in human kidney cortex. A new measure, the "population critical concentration" (PCC) with a clearly defined response rate, is suggested. A reanalysis of the published data indicates that the PCC-10 (10% response rate) for cadmium in kidney cortex is likely to be in the range 180-220 micrograms/g and the PCC-50 is likely to be about 25% higher.     

Retrospective Evaluation of Crestal Bone Changes Around Implants With Reduced Abutment Diameter Placed Non‐Submerged and at Subcrestal Positions: The Effect of Bone Grafting at Implant Placement

Background: There is limited information regarding the effect of grafting of the osteotomy after subcrestal implant placement. The primary aim of this study is to retrospectively evaluate the effect of bone grafting of the defect between the bone crest and the coronal aspect of implants with reduced abutment diameter placed non‐submerged and at subcrestal positions. Methods: Records of 50 consecutive patients treated with subcrestally placed dental implants grafted with a xenograft (Group A) and 50 consecutive patients with subcrestally placed dental implants without any grafting material (Group B) were reviewed. For each implant, the radiographs after placement were compared to images from the last follow‐up visit and evaluated regarding the following: 1) degree of subcrestal positioning of the implant, 2) changes of marginal hard‐tissue height over time, and 3) whether marginal hard‐tissue could be detected on the implant platform at the follow‐up visit. Results: The mean marginal loss of hard tissues was 0.11 ± 0.30 mm for Group A and 0.08 ± 0.22 mm for Group B. Sixty‐nine percent of the implants in Group A and 77% of the implants in Group B demonstrated hard tissue on the implant platform. There were no statistically significant differences between the groups regarding marginal peri‐implant hard‐tissue loss. Conclusion: The present study fails to demonstrate that grafting of the remaining osseous wound defect between the bone crest and the coronal aspect of the implant has a positive effect on marginal peri‐implant hard‐tissue changes.