Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis

Abstract

Background This split-mouth, double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD) after a 24–month follow-up. The radiographic distance from the CEJ to the bottom of the defect (BD) was considered the primary outcome. CEJ-BC and defect angle were secondary outcomes.

Methods Ten patients presenting 2 or more defects were selected. An individualized film holder was used to take standardized radiographs of the 43 defects, at baseline and after 24 months. Images were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle. Statistical analysis was performed in SPSS for Windows (version 5.2). Paired samples t test was used to compare test and control groups and to evaluate changes within each group. The level of significance was set at α = 0.05%.

Results After 24 months, a significant crestal bone loss was observed for EMD (1.01 mm; p = 0.049) but not for OFD (0.14 mm; p = 0.622). However, no differences were detected between groups (p = 0.37). Reduction of the bone defect depth was significant for OFD (0.70 mm; p = 0.005) but not for EMD (0.04 mm; p = 0.86), while no differences were detected between them (p = 0.87). Both EMD (0.69°; p = 0.82) and OFD (5.71°; p = 0.24) showed an improvement in defect angle measurements but no significant differences were observed after 24 months or between the groups (p = 0.35).

Conclusion Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24 months.

Trial registration ClinicalTrials.gov: NCT02195765

. Registered 17 July 2014.