A comparative study on the use of a HA/collagen/chondroitin sulphate biomaterial (Biostite) and a bovine-derived HA xenograft (Bio-Oss) in the treatment of deep intra-osseous defects

OBJECTIVES: This parallel-group, randomized, clinical trial was designed to evaluate the clinical outcome of deep intra-osseous defects following reconstructive surgery with the use of a synthetic hydroxyapatite/equine Type I collagen/chondroitin sulphate biomaterial (Biostite), as compared to a bovine-derived hydroxyapatite xenograft (Bio-Oss). MATERIAL AND METHODS: Twenty-four systemically healthy subjects with moderate to advanced periodontitis, 11 females and 13 males, aged 30-64 years, seven smokers, were selected. Patients presented with one interproximal deep intra-osseous defect (intra-osseous component >or=4 mm) as clinically and radiographically evaluated. Immediately before surgery and 12 months after surgery, pocket probing depth (PPD), clinical attachment level (CAL) and radiographic depth of the defect (DEPTH) were evaluated. RESULTS: Thirteen defects were treated with Biostite (test) and 11 defects with Bio-Oss (control). In the test group, PPD amounted to 7.8+/-1.3 mm before surgery, and decreased significantly to 3.6+/-1.6 mm 12 months following surgery, while in the control group PPD significantly decreased from 7.5+/-2.0 mm pre-surgery to 3.1+/-1.0 mm post-surgery. At 1 year, CAL gain and DEPTH gain were 2.9+/-1.9 and 2.5+/-1.4 mm, respectively, in the test group, and 4.0+/-2.4 mm and 3.1+/-1.8 mm, respectively, in the control group. No statistically significant differences for PPD reduction, CAL gain and DEPTH gain were detected between the groups. CONCLUSIONS: The results of the present study indicate that both Biostite and Bio-Oss grafting biomaterials have determined a clinically and statistically significant improvement in terms of CAL gain, PPD reduction and radiographic DEPTH gain when used for the treatment of deep intra-osseous defects