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

• Published in: Journal of clinical periodontology 1997-09, Vol.24 (9), p.697-704
• Main Authors: Zetterström, Olle, Andersson, Christer, Eriksson, Leif, Fredriksson, Anders, Friskopp, Johan, Heden, Gunnar, Jansson, Bernt, Lundgren, Tord, Nilveus, Rolf, Olsson, Anders, Renvert, Stefan, Salonen, Lars, Sjöström, Lars, Winell, Anders, Östgren, Anders, Gestrelius, Stina
• Format: Article
• Language: English
• Subjects: Adult; Aged; Alveolar Bone Loss - diagnostic imaging; Alveolar Bone Loss - surgery; Alveolar Bone Loss - therapy; Antibodies - blood; Antibody Formation; atopic; clinical trial; Combined Modality Therapy; Dental Enamel Proteins - administration & dosage; Dental Enamel Proteins - immunology; Dental Enamel Proteins - therapeutic use; Dentistry; enamel proteins; Female; Follow-Up Studies; Humans; Hypersensitivity - blood; immunoassay; Male; Middle Aged; Periodontal Attachment Loss - diagnostic imaging; Periodontal Attachment Loss - surgery; Periodontal Attachment Loss - therapy; Periodontitis - diagnostic imaging; Periodontitis - surgery; Periodontitis - therapy; Postoperative Complications; Radiography; regeneration; Safety; surgery; Surgical Flaps
• ISSN: 0303-6979; 1600-051X
• DOI: 10.1111/j.1600-051X.1997.tb00252.x

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®.