Objective: Aim of study is to evaluate the effect of Osteoinductal® in the treatment of deep intrabony defects, when compared to access flap (AF) surgery alone.
Method: 30 patients with one intrabony defect each were randomly treated with either AF+Osteoinductal® (test) or AF alone (control). Parameters evaluated at baseline and six months after surgery: PI, BOP, PD, GR, CAL. Postsurgical care - administration of antibiotica (Amoxicillin 3x500 mg/die one week, 0.2% Chlorhexidine rinses twice daily for two weeks. Statistical analysis - the Wilcoxon paired test for evaluation of the changes from baseline to six months, and the Mann-Whitney U independent test for comparisons between the groups.
Results:At six months, measurements revealed in the test group a reduction in mean PD from 8.60 ± 2.06 mm to 3.27 ± 1.39 (p<0.001) and a change in mean CAL from 10.20 ± 2.08 mm to 5.80 ± 2.37 (p<0.01). In the control group, mean PD was reduced from 7.20 ± 1.01 mm to 4.13 ± 1.41 (p<0.001) and mean CAL changed from 8.60 ± 1.96 mm to 6.87 ± 2.23 (p<0.01). Test treatment resulted in statistically higher PD reductions (p<0.0001) and CAL gains (p<0.001) than the control one. In the test group 93% of the sites (14 of 15) gained at least 3 mm of CAL, in the control group, only 26% (4 of 15) gained the same amount of CAL.
Conclusions:Results demonstrate: 1) at six months after the surgery both therapies resulted in significant PD reductions and CAL gains, and 2) the treatment with Osteoinductal® resulted in significantly higher CAL gains and PD reductions than treatment with AF surgery.