Treatment of intrabony defects with an enamel matrix protein derivative or bioabsorbable membrane: an 8-year follow-up split-mouth study

Abstract

Background: Treatments with either an enamel matrix protein derivative (EMD) or guided tissue regeneration (GTR) have been shown to promote periodontal regeneration. However, until recently, only limited data have been available on the long-term clinical results following these regenerative techniques. Therefore, the aim of this study was to present the 8-year results of a prospective, controlled, split-mouth clinical study evaluating the treatment of intrabony defects with EMD or GTR.

Methods: Ten patients, each of whom displayed one pair of intrabony defects located contralaterally in the same jaw, were randomly treated with EMD or with GTR by means of bioabsorbable membranes. The following clinical parameters were evaluated at baseline and at 1 and 8 years after treatment: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). The primary outcome variable was CAL. No statistically significant differences between the groups were found at baseline.

Results: The sites treated with EMD demonstrated a mean CAL change from 9.5 +/- 1.2 mm to 6.3 +/- 1.3 mm (P <0.001) and 6.7 +/- 1.6 mm (P <0.001) at 1 and 8 years, respectively. No statistically significant differences were found between the 1- and 8-year results. Sites treated with GTR showed a mean CAL change from 9.7 +/- 1.3 mm to 6.7 +/- 0.9 mm (P <0.001) at 1 year and 6.8 +/- 1.2 mm (P <0.001) at 8 years. The CAL change between 1 and 8 years did not present statistically significant differences. Between the treatment groups, no statistically significant differences in any of the investigated parameters were observed at 1 and at 8 years. However, the study does not have the statistical power to rule out the possibility of a difference between the two groups.

Conclusions: Within their limits, the present results indicate the following: 1) the clinical improvements obtained following treatment with EMD or GTR can be maintained over a period of 8 years; and 2) further studies of much higher power need to be performed to support equivalence.