title: A multicenter study evaluating the sensitization potential of enamel matrix derivative after treatment of two infrabony defects.
abstract: BACKGROUND
  Several studies reported some success toward regeneration in infrabony defects using enamel matrix derivative (EMD). Clinically and statistically significant improvements in probing depth reduction, clinical attachment levels, and bone fill have been demonstrated. This multi-center study evaluated the potential for sensitization to EMD in a subgroup of periodontal patients treated at least twice with at least 2 months between treatments.
  
  
  METHODS
  Three hundred seventy-six (376) patients in 11 university-based postgraduate periodontics programs and five private practices were selected. Surgeries were performed on infrabony defects. Following reflection of mucoperiosteal flaps and debridement of the root surface and defect, root conditioning (either citric acid pH = 1 or 24% EDTA) was performed and the site was irrigated with sterile saline. Enamel matrix derivative was reconstituted and applied to the exposed root surface and the bony defect. Flaps were sutured and pressure applied for 5 minutes. The second test defect was treated in a similar manner at least 8 weeks after the first surgery. The patient was given a diary card where any subjective adverse events (erythema, swelling, itching, headache, root hypersensitivity, or pain) were recorded at weeks 1 and 2 post-surgery. In addition, objective adverse events (gingival inflammation, ulcers, abscess, cratering, and lesions) were recorded by the investigator on an adverse event form.
  
  
  RESULTS
  No clinical adverse reactions to multiple applications of EMD were noted. Of 376 patients, two were referred to a dermatologist for evaluation, but neither had signs indicating any adverse events due to EMD treatment. Instead their reactions were classified as a small local abscess and tinea cruris. The single immunoassay performed (on the patient with a small local abscess) did not demonstrate any EMD-reactive antibodies, neither IgE nor IgG. Other subjective/objective reactions that occurred during this study were of the type that are commonly experienced by patients immediately following periodontal surgery, but were not related to EMD. They included headache, swelling, itching, pain, and root hypersensitivity.
  
  
  CONCLUSIONS
  This study demonstrated a lack of clinical adverse reactions following two separate applications of EMD. Any subjective/objective adverse reactions experienced by the patient were typical complications following routine periodontal surgery and were not directly related to the use of enamel matrix derivative.
authors.affiliation: Department of Implant Dentistry, New York University, New York, NY, USA dr.froum@verizon.net
authors.forename: Stuart
authors.initials: S
authors.lastname: Froum
authors.forename: Mea
authors.initials: M
authors.lastname: Weinberg
authors.forename: John
authors.initials: J
authors.lastname: Novak
authors.forename: Jason
authors.initials: J
authors.lastname: Mailhot
authors.forename: James
authors.initials: J
authors.lastname: Mellonig
authors.forename: Thomas
authors.initials: T
authors.lastname: Van Dyke
authors.forename: Pamela
authors.initials: P
authors.lastname: McClain
authors.forename: Panos N
authors.initials: PN
authors.lastname: Papapanou
authors.forename: Gail
authors.initials: G
authors.lastname: Childers
authors.forename: Sebastian
authors.initials: S
authors.lastname: Ciancio
authors.forename: Tim
authors.initials: T
authors.lastname: Blieden
authors.forename: Alan
authors.initials: A
authors.lastname: Polson
authors.forename: Gary
authors.initials: G
authors.lastname: Greenstein
authors.forename: Raymond
authors.initials: R
authors.lastname: Yukna
authors.forename: Marshall Lynn
authors.initials: ML
authors.lastname: Wallace
authors.forename: Mark
authors.initials: M
authors.lastname: Patters
authors.forename: Charles
authors.initials: C
authors.lastname: Wagener
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016301:Alveolar Bone Loss / Q000188:drug therapy* / Q000601:surgery; D001861:Bone Regeneration / Q000187:drug effects; D003746:Dental Enamel Proteins / Q000009:adverse effects* / Q000276:immunology; D004342:Drug Hypersensitivity / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors
chemical_list: D003746:Dental Enamel Proteins; C109069:enamel matrix proteins