A multi-centre randomized controlled clinical trial on the treatment of intra-bony defects with enamel matrix derivatives/synthetic bone graft or enamel matrix derivatives alone: results after 12 months

Abstract

Comparison of the clinical and radiographic outcomes of a combination of enamel matrix derivatives (EMD) and a synthetic bone graft (EMD/SBG) with EMD alone in wide (≥2 mm) and deep (≥4 mm) one- and two- wall intra-bony defects 12 months after treatment. Seventy-three patients with chronic periodontitis and one wide (≥2 mm) and deep (≥4 mm) intra-bony defect were recruited in five centres in Germany. During surgery, defects were randomly assigned to EMD/SBG (test) or EMD (control). Assessments at baseline, after 6 and 12 months included bone sounding, attachment levels, probing pocket depths, bleeding on probing, and recessions. Changes in defect fill were recorded radiographically. Both treatment modalities led to significant clinical improvements. In the EMD/SBG group a mean defect fill of 2.7 ± 1.9 mm was calculated, in the EMD group the defect fill was 2.8 ± 1.6 mm. A mean gain in clinical attachment of 1.7 ± 2.1 mm in the test group and 1.9 ± 1.7 mm in the control group after 1 year was observed. Radiographic analysis confirmed for both groups that deeper defects were associated with greater defect fill. The results show comparable clinical and radiographic outcomes following both treatment modalities 12 months after treatment.