Al Machot Elyan, Hoffmann Thomas, Lorenz Katrin, Khalili Ihssan, Noack Barbara
Department of Periodontology, Medical Faculty Carl Gustav Carus, TU Dresden, Fetscherstraße 74, 01307 Dresden, Germany.
Biomed Res Int. 2014;2014:786353. doi: 10.1155/2014/786353. Epub 2014 Feb 9.
Periodontitis is an inflammatory process in response to dental biofilm and leads to periodontal tissue destruction. The aim of this study was the comparison of outcomes using either an enamel matrix derivative (EMD) or a nanocrystalline hydroxyapatite (NHA) in regenerative periodontal therapy after 6 and 12 months.
Using a parallel group, prospective randomized study design, we enrolled 19 patients in each group. The primary outcome was bone fill after 12 months. Attachment gain, probing pocket depth (PPD) reduction, and recession were secondary variables. Additionally, early wound healing and adverse events were assessed. Data analysis included test of noninferiority of NHA group (test) compared to EMD group (reference) in bone fill. Differences in means of secondary variables were compared by paired t-test, frequency data by exact χ(2) test.
Both groups showed significant bone fill, reduction of PPD, increase in recession, and gain of attachment after 6 and 12 months. No significant differences between groups were found at any time point. Adverse events were comparable between both groups with a tendency of more complaints in the NHA group.
The clinical outcomes were similar in both groups. EMD could have some advantage compared to NHA regarding patients comfort and adverse events. The trial is registered with ClinicalTrials.gov NCT00757159.
牙周炎是一种对牙菌斑产生的炎症反应,会导致牙周组织破坏。本研究的目的是比较在再生牙周治疗6个月和12个月后,使用釉基质衍生物(EMD)或纳米晶羟基磷灰石(NHA)的治疗效果。
采用平行组前瞻性随机研究设计,每组纳入19例患者。主要观察指标是12个月后的骨填充情况。附着获得、探诊深度(PPD)降低和退缩是次要变量。此外,还评估了早期伤口愈合情况和不良事件。数据分析包括NHA组(试验组)与EMD组(参照组)在骨填充方面的非劣效性检验。次要变量均值的差异采用配对t检验进行比较,频率数据采用确切χ²检验。
两组在6个月和12个月时均显示出显著的骨填充、PPD降低、退缩增加和附着获得。在任何时间点两组之间均未发现显著差异。两组的不良事件相当,NHA组的投诉倾向更多。
两组的临床结果相似。在患者舒适度和不良事件方面,EMD可能比NHA具有一些优势。该试验已在ClinicalTrials.gov注册,注册号为NCT00757159。