title: Clinical evaluation of a newly designed single-stage craniofacial implant: a pilot study.
abstract: BACKGROUND
  Placing craniofacial implants in a 2-stage procedure requires an additional second-stage surgery that is tedious for patients and clinicians and results in additional cost.
  
  
  OBJECTIVE
  The purpose of this study was to clinically evaluate the use of a newly designed craniofacial implant for retaining facial prostheses, placed in a single-stage surgical procedure.
  
  
  METHODS
  Twenty-one newly designed craniofacial implants (OsteoCare Implant System) were placed in 7 patients, all seeking implant-retained auricular prostheses, using a single-stage surgical procedure. Modified O-ring abutments were directly screwed onto the implants at the time of surgery. Plastic washers were attached to the O-ring heads of the exposed abutments to avoid skin overgrowth to allow a single-stage surgical procedure. After a delayed loading period of 4 months, a silicone prosthetic ear was fabricated and retained using clips over the O-ring abutments. Implants and surrounding tissues were clinically evaluated at 1, 6, and 12 months following prosthesis insertion. The following were evaluated: periimplant abutment sebaceous crusting, periimplant abutment exudate, skin thickness, periimplant abutment tissue reaction, and implant mobility. Data was collected and statistically analyzed using the nonparametric Friedman's test for overall comparisons and Wilcoxon signed rank test for post hoc assessment of significance between follow-up periods.
  
  
  RESULTS
  None of the implants failed to osseointegrate, providing a survival rate of 100%. Periimplant abutment sebaceous crusting values were significantly reduced at the 12-month test session (P<.05). Periimplant abutment skin thickness was also significantly reduced (P<.05) between the 6- and 12-month, and 1- and 12-month, follow-up visits. No significant difference was found throughout the follow-up period for periimplant abutment exudates and tissue reactions. None of the implants showed any signs of mobility throughout the study period.
  
  
  CONCLUSIONS
  The use of the single-stage surgical procedure, together with the newly designed craniofacial implants, provided a high survival rate for an evaluation period of up to 2.5 years in the present investigation.
authors.affiliation: Prosthodontic Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt. moataz_khamis@yahoo.com
authors.forename: Mohamed Moataz
authors.initials: MM
authors.lastname: Khamis
authors.forename: Ahmed
authors.initials: A
authors.lastname: Medra
authors.forename: John
authors.initials: J
authors.lastname: Gauld
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D004431:Ear, External; D005122:Exudates and Transudates; D005260:Female; D005549:Foreign-Body Reaction; D006801:Humans; D008297:Male; D009068:Movement; D016348:Osseointegration; D010865:Pilot Projects; D019736:Prostheses and Implants; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods*; D012629:Sebum; D012867:Skin / Q000033:anatomy & histology; D018709:Statistics, Nonparametric