Effectiveness of Regenafil^TM in Treating Intrabony Pockets - 6-Month Results

The aim of this study was to evaluate the effect of Reganefil^TM allograft paste in the treatment of one-and two-wall intrabony pockets. The material is a thermoplastic preparation of demineralized bone in a gelatin carrier. When warmed up to between 43 – 49°C the graft material is extrude-able from a syringe and is moldable, but does not dissolve in body fluids at normal body temperature. After signing informed consent, 28 subjects with moderate to severe adult chronic periodontal disease volunteered to participate in the study. Forty-four defects were randomized to receive either conventional replaced flap procedure alone or in combination with the placement of Regenafil^TM. Post-surgery subjects were advised to locally apply 0.12% chlorhexidine solution twice daily for 3 weeks. Subjects were recalled for oral hygiene control after 3 months and for reevaluation of pocket depth, clinical attachment level and radiographic bone level at 6 months. Reduction in pocket depth was 0.4 mm greater for the test group compared to the control (NS). Bone level, as measured by linear measurements on radiographs, was 0.3 mm greater for the test group (NS). Gain of clinical attachment level was 1.5 mm greater in the test group compared to the control group (p=0.01). Mean gain in the test group was 1.8 mm. Gain of ³2 mm was 42% in the test group versus 15% in the control group. The results demonstrate that the use of Regenafil^TM in the treatment of intrabony pockets significantly improves gain of clinical attachment level compared to a control over a 6-month period. Supported by Regeneration Technologies, Inc., Alachua, Florida.