BACKGROUND: Promising clinical outcomes have been reported with the combination of enamel matrix derivative (EMD) and allograft materials. Direct comparison between EMD with a freeze-dried bone allograft (FDBA) and a demineralized FDBA (DFDBA) was evaluated in one case series study. To date, no randomized controlled trial has been reported. Therefore, a well-controlled randomized clinical trial was conducted to determine the relative efficacy of EMD/FDBA versus EMD/DFDBA when managing intrabony defects. METHODS: A randomized parallel trial was conducted in a private practice from April 2004 to October 2011. Sixty-nine patients were randomly assigned to one of three groups: EMD/FDBA (EF) intervention group (n = 23), EMD/DFDBA (ED) intervention group (n = 23), and EMD alone without graft material (E) as a negative control group (n = 23). All of the grafting material had minocycline added. Each patient had an intrabony defect. The primary outcomes were the absolute change in probing depth (PD) reduction and clinical attachment level (CAL) gain from baseline to 1- and 3-year follow-up. Intrabony defects were surgically treated with EMD/FDBA, EMD/DFDBA, or EMD alone. RESULTS:Sixty-seven patients (EF, n = 21: ED, n = 23; E, n = 23) were analyzed. All groups demonstrated significant improvement in PD reduction and CAL gain from baseline. The changes for PD were as follows (mm, 95% confidence interval [CI]): at 1 year: EF (4.4 mm, 4.0 to 4.7), ED (3.7 mm, 3.4 to 4.0), and E (control) (3.3 mm, 3.0 to 3.6); at 3 years: EF (4.4 mm, 4.1 to 4.8), ED (3.7 mm, 3.4 to 4.0), and E (3.1 mm, 2.8 to 3.4). The changes for CAL were as follows (mm, 95% CI): at 1 year: EF (4.1 mm, 3.8 to 4.5), ED (3.5 mm, 3.0 to 4.0), and E (3.0 mm, 2.5 to 3.6); at 3 years: EF (4.2 mm, 3.7 to 4.7), ED (3.6 mm, 3.1 to 4.1), and E (3.0 mm, 2.5 to 3.5). The intervention groups (EF and ED) showed better treatment outcomes than the control group at 1 and 3 years. Statistically, the two bone-graft groups were not significantly different from each other at 1 and 3 years. CONCLUSIONS: Both EMD/FDBA and EMD/DFDBA interventions resulted in greater soft tissue improvement at 1 and 3 years of follow-up compared to EMD alone. Both graft materials worked well in managing deep intrabony defects when combined with EMD.
RCT Entities:
BACKGROUND: Promising clinical outcomes have been reported with the combination of enamel matrix derivative (EMD) and allograft materials. Direct comparison between EMD with a freeze-dried bone allograft (FDBA) and a demineralized FDBA (DFDBA) was evaluated in one case series study. To date, no randomized controlled trial has been reported. Therefore, a well-controlled randomized clinical trial was conducted to determine the relative efficacy of EMD/FDBA versus EMD/DFDBA when managing intrabony defects. METHODS: A randomized parallel trial was conducted in a private practice from April 2004 to October 2011. Sixty-nine patients were randomly assigned to one of three groups: EMD/FDBA (EF) intervention group (n = 23), EMD/DFDBA (ED) intervention group (n = 23), and EMD alone without graft material (E) as a negative control group (n = 23). All of the grafting material had minocycline added. Each patient had an intrabony defect. The primary outcomes were the absolute change in probing depth (PD) reduction and clinical attachment level (CAL) gain from baseline to 1- and 3-year follow-up. Intrabony defects were surgically treated with EMD/FDBA, EMD/DFDBA, or EMD alone. RESULTS: Sixty-seven patients (EF, n = 21: ED, n = 23; E, n = 23) were analyzed. All groups demonstrated significant improvement in PD reduction and CAL gain from baseline. The changes for PD were as follows (mm, 95% confidence interval [CI]): at 1 year: EF (4.4 mm, 4.0 to 4.7), ED (3.7 mm, 3.4 to 4.0), and E (control) (3.3 mm, 3.0 to 3.6); at 3 years: EF (4.4 mm, 4.1 to 4.8), ED (3.7 mm, 3.4 to 4.0), and E (3.1 mm, 2.8 to 3.4). The changes for CAL were as follows (mm, 95% CI): at 1 year: EF (4.1 mm, 3.8 to 4.5), ED (3.5 mm, 3.0 to 4.0), and E (3.0 mm, 2.5 to 3.6); at 3 years: EF (4.2 mm, 3.7 to 4.7), ED (3.6 mm, 3.1 to 4.1), and E (3.0 mm, 2.5 to 3.5). The intervention groups (EF and ED) showed better treatment outcomes than the control group at 1 and 3 years. Statistically, the two bone-graft groups were not significantly different from each other at 1 and 3 years. CONCLUSIONS: Both EMD/FDBA and EMD/DFDBA interventions resulted in greater soft tissue improvement at 1 and 3 years of follow-up compared to EMD alone. Both graft materials worked well in managing deep intrabony defects when combined with EMD.
Entities:
Keywords:
Allografts; bone and bones; clinical trials; enamel matrix protein; randomized; regeneration; tissues
Authors: Mohammad Hasan Samandari; Abbas Haghighat; Nakisa Torabinia; Mehdi Taghian; Leyli Sadri; Vahid Naemy Journal: Dent Res J (Isfahan) Date: 2016-09