Clinical evaluation of demineralized freeze-dried bone allograft and enamel matrix derivative versus enamel matrix derivative alone for the treatment of periodontal osseous defects in humans.

BACKGROUND

A recent study suggests that the addition of enamel matrix derivative to demineralized freeze-dried bone allograft may enhance osseoinduction. The purpose of this study was to evaluate the use of demineralized freeze-dried bone allograft (DFDBA) in combination with enamel matrix derivative (EMD + DFDBA) compared to enamel matrix derivative (EMD) alone in the treatment of human intrabony periodontal defects.

METHODS

Forty patients with a total of 67 sites (intrabony defect > or = 3 mm deep) were selected to participate in this single-masked, parallel design, randomized, controlled clinical trial. Each subject received either EMD alone (34 sites) or in combination with DFDBA (33 sites). Soft tissue measurements included probing depth (PD), clinical attachment level (CAL), and recession. Hard tissue measurements included defect depth, alveolar crestal resorption, and defect morphology. Following 6 months of healing, all soft tissue measurements were repeated. Forty-nine sites (EMD + DFDBA = 26 sites, EMD alone = 23 sites) were surgically reentered. Statistical analyses were performed using unpaired and paired Student t tests.

RESULTS

Analyses showed a significant improvement in soft tissue parameters for both treatment groups (P < 0.001) as compared to preoperative measurements. There were no statistical differences between treatment groups. The probing depth reduction (PDR) for the EMD + DFDBA was 3.6 +/- 0.2 mm, while the EMD alone had a PDR of 4.0 +/- 0.3 mm. The CAL gain for the EMD + DFDBA group was 3.0 +/- 0.3 mm and 3.2 +/- 0.3 mm for the EMD alone group. The mean value for bone fill in the EMD + DFDBA group was 3.7 +/- 0.2 mm (74.9%), while the EMD alone group demonstrated a mean bone fill of 2.6 +/- 0.4 mm (55.3%). While there were no significant differences between the two treatments with regards to soft tissue measurements, the combination of EMD + DFDBA therapy yielded statistically significant improvements in bone fill, crestal resorption, and percentage of sites gaining greater than 50% and 90% bone fill when compared to EMD alone (P < 0.001).

CONCLUSION

The results of this study indicate that there may be an enhancement of hard tissue parameters when enamel matrix derivative is added to demineralized freeze-dried bone allograft.