title: Clinical evaluation of calcium sulfate in combination with demineralized freeze-dried bone allograft for the treatment of human intraosseous defects.
abstract: BACKGROUND
  Medical-grade calcium sulfate (CS) is a biocompatible, bioabsorbable, and clinically versatile ceramic for use in bone repair. This study compared the clinical efficacy of a combination of calcium sulfate dihydrate, as a binder and barrier, and demineralized freeze-dried bone allograft (DFDBA) to polytetrafluoroethylene (ePTFE) and DFDBA for the treatment of human periodontal defects.
  
  
  METHODS
  Two intrabony defects were compared in each of 19 patients with chronic periodontitis. After initial preparation, full-thickness mucoperiosteal flaps were elevated, osseous defects debrided, and the roots prepared (ultrasonic, hand curets, and tetracycline conditioning). Defects were randomly treated with either a combination graft of DFDBA with CS (4:1) covered by a CS barrier or with DFDBA and fitted with an ePTFE barrier. Flaps were coronally positioned to obtain primary closure. Clinical soft tissue measurements were recorded at 6 months, and all study sites were surgically reentered for evaluation.
  
  
  RESULTS
  The mean presurgical measurements for defects randomized to the CS and ePTFE treatments, respectively, were similar for attachment level (AL; 6.2 +/- 1.8 mm and 6.1 +/- 1.7 mm), probing depth (PD; 6.3 +/- 1.1 mm and 6.2 +/- 1.1 mm), and gingival recession (0.1 +/- 1.9 mm and 0.2 +/- 1.4 mm). Defects treated with CS or ePTFE demonstrated statistically significant (P < or = 0.0001) reductions in mean PD (2.7 +/- 1.4 mm and 3.4 +/- 1.3 mm, respectively) and gains in mean AL (1.8 +/- 1.5 mm and 1.7 +/- 1.4 mm, respectively). Recession increased by 0.8 +/- 1.4 mm at CS sites and 1.6 +/- 1.7 mm at ePTFE-treated sites (P < or = 0.05). Pretreatment mean defect depths were 4.1 +/- 1.0 mm and 3.7 +/- 1.0 mm for CS and ePTFE sites, respectively. Reentry evaluations revealed a mean defect fill of 2.7 +/- 1.5 mm and 2.5 +/- 0.9 mm for the CS and ePTFE sites, respectively, with a corresponding mean defect resolution of 80.3 +/- 18.7% and 76.7 +/- 18.5%. The CS and ePTFE sites did not differ significantly in mean defect fill or defect resolution.
  
  
  CONCLUSIONS
  The results of this study indicate that calcium sulfate, when used as a binder and barrier in combination with DFDBA, supports significant clinical improvement in intrabony defects, as evidenced by reductions in probing depth, gains in clinical attachment level, and defect fill and resolution. Calcium sulfate represents an important alternative to non-resorbable ePTFE barriers in combination with DFDBA for the treatment of intrabony defects.
authors.affiliation: Department of Periodontics, University of Maryland, Baltimore, MD 21201, USA. MEA001@dental.umaryland.edu
authors.forename: Mary E
authors.initials: ME
authors.lastname: Aichelmann-Reidy
authors.forename: Carlette D
authors.initials: CD
authors.lastname: Heath
authors.forename: Mark A
authors.initials: MA
authors.lastname: Reynolds
mesh_terms: D000328:Adult; D016301:Alveolar Bone Loss / Q000601:surgery*; D000539:Alveolar Process / Q000473:pathology; D001672:Biocompatible Materials / Q000627:therapeutic use*; D016025:Bone Transplantation; D002133:Calcium Sulfate / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005889:Gingival Recession / Q000601:surgery; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000601:surgery; D010514:Periodontal Pocket / Q000601:surgery; D010518:Periodontitis / Q000601:surgery; D011138:Polytetrafluoroethylene; D018709:Statistics, Nonparametric
chemical_list: D001672:Biocompatible Materials; D008567:Membranes, Artificial; D011138:Polytetrafluoroethylene; D002133:Calcium Sulfate