1. 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.
- Author
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Meyle, Joerg, Hoffmann, Thomas, Topoll, Heinz, Heinz, Bernd, Al-Machot, Eli, Jervøe-Storm, Pia-Merete, Meiß, Christian, Eickholz, Peter, and Jepsen, Sören
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BONE substitutes , *HYPOTHESIS , *ANALYSIS of variance , *BONE resorption , *BONE grafting , *CALIBRATION , *CLINICAL trials , *COMPUTER software , *DENTAL enamel , *LONGITUDINAL method , *MEDICAL cooperation , *RESEARCH , *STATISTICAL sampling , *DENTAL radiography , *U-statistics , *SAMPLE size (Statistics) , *DATA analysis , *STATISTICAL significance , *HUMAN research subjects , *CASE-control method , *PATIENT selection , *THERAPEUTICS - Abstract
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 ± 1.9mm was calculated, in the EMD group the defect fill was 2.8 ± 1.6 mm. A mean gain in clinical attachment of 1.7 ± 2.1mm in the test group and 1.9 ± 1.7mm 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. [ABSTRACT FROM AUTHOR]
- Published
- 2011
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