Resumen de Efficacy of Enamel Matrix Derivative With Freeze-Dried Bone Allograft or Demineralized Freeze-Dried Bone Allograft in Intrabony Defects: A Randomized Trial
Shigeki Ogihara, Dennis Tarnow
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.
Allografts, especially freeze-dried bone allograft (FDBA) and demineralized FDBA (DFDBA), are most commonly used to correct osseous periodontal defects. A study demonstrated significant superior gains in osseous fill (OF) with DFDBA compared to open flap debridement (OFD) alone.1 DFDBA supports the formation of a new attachment apparatus: new bone, cementum, and periodontal ligament, when placed in intrabony defects.2,3 A systematic review of this material also indicated that DFDBA is inconsistent with its osteoinductivity due to donor age and processing.4 This same meta-analysis failed to support the use of FDBA in the treatment of intrabony defects because of insufficient data that would meet inclusion criteria.4 Thus, the use of these allografts as monotherapies may be limited in their use.
Recent attention has focused on the potential for biologic mediators to improve wound healing and enhance the clinical benefits of bone replacement grafts.5 This idea originated in the work of Bowers and Reddi.6 Enamel matrix derivatives (EMDs) have been shown to promote wound healing and new periodontal tissue formation.7 Systematic reviews suggested that the use of EMD for periodontal osseous defects yields significantly higher soft tissue improvements compared to OFD alone.8-10 However, the application of EMD was less effective in non-supporting defects.11 Therefore, the addition of a bone graft such as DFDBA to EMD enhanced the outcomes for repairing these intrabony defects. In an experimental animal study, Boyan et al. reported that the combination of DFDBA and EMD resulted in enhanced bone formation compared to DFDBA alone.12 EMD as a osteopromotor increased the osteoinductive potential of active DFDBA.12 A comparative study examined the clinical outcomes of EMD/DFDBA compared to EMD alone in the treatment of intrabony defects.13 EMD/DFDBA yielded statistically significant improvement in OF.13 A systematic review suggested that the additional use of a graft (autogenous bone, DFDBA) seemed to enhance the clinical outcome of EMD.14 In contrast, there were studies to investigate whether the addition of EMD to a bone graft enhanced the outcomes seen for regenerating these intrabony defects. Hoidal et al.15 evaluated the effectiveness of EMD/DFDBA compared to DFDBA alone in the treatment of intraosseous defects at 6 months post-surgery. They found that the addition of EMD to DFDBA provided no statistically significant improvement in the soft and hard tissue compared to DFDBA alone.15 A recent randomized, controlled clinical trial compared EMD/DFDBA to DFDBA alone in the treatment of intrabony defects at 12 months post-surgery.16 Statistically significant differences were found between EMD/DFDBA and DFDBA alone in PD (probing depth) reduction (5.0 versus 4.0 mm), CAL gain (4.0 versus 3.3 mm), and OF (4.0 versus 3.5 mm).16 Moreover, a study comparing FDBA to DFDBA failed to show superiority of either material by similar OF at 6 months.17 In contrast, a case series reported a trend toward better efficacy in attachment level gains when combining FDBA/EMD versus DFDBA/EMD for intrabony defects, suggesting that the scaffold may matter.18 These studies raise the question of whether FDBA could have a greater potential therapeutic role as a scaffolding agent with EMD than DFDBA. However, to date, there has been no randomized, controlled clinical trial to answer this question. Therefore, a well-controlled randomized clinical trial to determine the efficacy of EMD/FDBA versus EMD/DFDBA for intrabony defects is conducted.
