Sculean Anton, Schwarz Frank, Miliauskaite Asta, Kiss Alice, Arweiler Nicole, Becker Jürgen, Brecx Michel
Department of Periodontology, Radboud University Medical Center, Nijmegen, The Netherlands.
J Periodontol. 2006 Nov;77(11):1879-86. doi: 10.1902/jop.2006.060002.
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.
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.
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.
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.
已证实使用釉基质蛋白衍生物(EMD)或引导组织再生(GTR)进行治疗可促进牙周组织再生。然而,直到最近,关于这些再生技术长期临床结果的数据仍然有限。因此,本研究的目的是展示一项前瞻性、对照、分口临床研究的8年结果,该研究评估了使用EMD或GTR治疗骨内缺损的效果。
10名患者,每人在同一颌骨的对侧各有一对骨内缺损,通过生物可吸收膜随机接受EMD或GTR治疗。在基线以及治疗后1年和8年评估以下临床参数:菌斑指数(PI)、牙龈指数(GI)、探诊出血(BOP)、探诊深度(PD)、牙龈退缩(GR)和临床附着水平(CAL)。主要观察变量为CAL。两组在基线时未发现统计学上的显著差异。
接受EMD治疗的部位在1年和8年时的平均CAL变化分别从9.5±1.2mm变为6.3±1.3mm(P<0.001)和6.7±1.6mm(P<0.001)。1年和8年的结果之间未发现统计学上的显著差异。接受GTR治疗的部位在1年时的平均CAL变化从9.7±1.3mm变为6.7±0.9mm(P<0.001),在8年时为6.8±1.2mm(P<0.001)。1年至8年的CAL变化没有统计学上的显著差异。在治疗组之间,1年和8年时在任何研究参数上均未观察到统计学上的显著差异。然而,该研究没有足够的统计效力排除两组之间存在差异的可能性。
在其局限性范围内,目前的结果表明:1)使用EMD或GTR治疗后获得的临床改善在8年期间可以维持;2)需要进行更具效力的进一步研究以支持等效性。