Treatment of intrabony defects with enamel matrix proteins or barrier membranes: results from a multicenter practice-based clinical trial.

BACKGROUND: This prospective multicenter, randomized, controlled clinical trial compared the clinical outcomes of enamel matrix proteins (EMD) versus placement of a bioabsorbable membrane in conjunction with guided tissue regeneration (GTR).

METHODS: Seventy-five patients with advanced chronic periodontitis were recruited in seven centers in three countries. All patients had at least one intrabony defect of > or = 3 mm. Heavy smokers (> or = 20 cigarettes/day) were excluded. The surgical procedures included access for root instrumentation using the simplified papilla preservation flap and either the application of EMD or the placement of a GTR membrane. At baseline and 1 year following the interventions, clinical attachment levels (CAL), probing depths (PD), recession (REC), full-mouth plaque scores, and full-mouth bleeding scores were assessed. A total of 67 patients completed the study.

RESULTS: At 1 year, the EMD defects gained 3.1 +/- 1.8 mm of CAL, versus 2.5 +/- 1.9 mm for GTR defects. Probing depth reduction was 3.8 +/- 1.5 mm and 3.3 +/- 1.5 mm, respectively. A multivariate analysis indicated that the differences between EMD and GTR treatments were not significant while a center effect and baseline PD significantly influenced CAL gains. No significant differences in terms of frequency distribution of the outcomes were observed. All cases treated with GTR presented at least one surgical complication, mostly membrane exposure, while only 6% of EMD treated sites displayed complications (P < 0.0001).

CONCLUSIONS: The results of this trial failed to demonstrate superiority of one treatment modality over the other. GTR outcomes in this trial were lower than anticipated based on previous evidence. This was attributed to the high prevalence of post-surgical complications in the GTR group.