Clinical outcomes after treatment of periodontal intrabony defects with nanocrystalline hydroxyapatite (Ostim) or enamel matrix derivatives (Emdogain): a randomized controlled clinical trial

Elyan Al Machot, Thomas Hoffmann, Katrin Lorenz, Ihssan Khalili, Barbara Noack, Elyan Al Machot, Thomas Hoffmann, Katrin Lorenz, Ihssan Khalili, Barbara Noack

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Figures

Figure 1
Figure 1
Study design. PPD: probing pocket depth; RAL: relative attachment level; RGR: relative gingival recession; PP: patient perception; EHI: early wound-healing index.
Figure 2
Figure 2
Intraoperative view of the intrabony defect after debridement. All clinical parameters were assessed at six sites per tooth with a standard periodontal manual probe (PCP-UNC 15, Hu-Friedy, Leimen, Germany) using an acrylic customized stent with markings at six fixed reference points. The same stent was used for all clinical measurements before and after surgery.
Figure 3
Figure 3
Distribution (%) of defect types as assessed during surgical intervention. NHA: nanocrystalline hydroxyapatite; EMD: enamel matrix derivate.
Figure 4
Figure 4
Distribution (%) of patient perceptions 1 week after treatment. *P = 0.046; exact χ2 test. EMD: enamel matrix derivate; NHA: nanocrystalline hydroxyapatite.
Figure 5
Figure 5
Distribution (%) of early wound-healing index at the treated sites, at 1 and 2 weeks after treatment. No significant differences between groups (7 days: P = 0.511; 14 days: P = 0.904, Mann-Whitney U test) EMD: enamel matrix derivate; NHA: nanocrystalline hydroxyapatite.

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