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.

OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: The results show comparable clinical and radiographic outcomes following both treatment modalities 12 months after treatment.