| 1. |
- Calon, T. G. A., et al.
(författare)
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Minimally Invasive Ponto Surgery Versus the Linear Incision Technique With Soft Tissue Preservation for Bone Conduction Hearing Implants: A Multicenter Randomized Controlled Trial
- 2018
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Ingår i: Otology & Neurotology. - : Ovid Technologies (Wolters Kluwer Health). - 1531-7129 .- 1537-4505. ; 39:7, s. 882-893
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Tidskriftsartikel (refereegranskat)abstract
- Objective:To compare the surgical outcomes of the Minimally Invasive Ponto Surgery (MIPS) technique with those of the linear incision technique with soft-tissue preservation for bone-anchored hearing systems (BAHS).Design:Sponsor-initiated multicenter, open, randomized, controlled clinical trial.Setting:Maastricht University Medical Centre, Ziekenhuisgroep Twente and Medisch Centrum Leeuwarden, all situated in The Netherlands.Participants:Sixty-four adult patients eligible for unilateral BAHS surgery.Interventions Single-stage BAHS surgery with 1:1 randomization to the linear incision technique with soft-tissue preservation (control) or the MIPS (test) group.Primary and Secondary Outcome Measurements:Primary objective: compare the incidence of inflammation (Holgers Index 2) during 12 weeks' follow-up after surgery. Secondary objectives: skin dehiscence, pain scores, loss of sensibility around the implant, soft-tissue overgrowth, skin sagging, implant extrusion, cosmetic results, surgical time, wound healing and Implant Stability Quotient measurements.Results:Sixty-three subjects were analyzed in the intention-to-treat population. No significant difference was found for the incidence of inflammation between groups. Loss of skin sensibility, cosmetic outcomes, skin sagging, and surgical time were significantly better in the test group. No statistically significant differences were found for dehiscence, pain, and soft-tissue overgrowth. A nonsignificant difference in extrusion was found for the test group. The Implant Stability Quotient was statistically influenced by the surgical technique, abutment length, and time.Conclusion:No significant differences between the MIPS and the linear incision techniques were observed regarding skin inflammation. MIPS results in a statistically significant reduction in the loss of skin sensibility, less skin sagging, improved cosmetic results, and reduced surgical time. Although nonsignificant, the implant extrusion rate warrants further research.
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| 2. |
- Calon, T. G. A., et al.
(författare)
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Microbiome on the Bone-Anchored Hearing System: A Prospective Study
- 2019
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Ingår i: Frontiers in Microbiology. - : Frontiers Media SA. - 1664-302X. ; 10
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Tidskriftsartikel (refereegranskat)abstract
- The bone-anchored hearing system (BAHS) has evolved to a common treatment option for various types of hearing revalidation. The BAHS consists of an implant in the skull that breeches the skin. Soft tissue reactions are a common complication associated with BAHS and are generally poorly understood. This study aims to investigate the influence of BAHS and associated skin reactions around the implant. A total of 45 patients were prospectively followed from implantation up to at least 1 year. Swabs were obtained at baseline, 12 weeks follow-up and during cases of inflammation (Holgers score >= 2). The microbiota was assessed using IS-proTM, a bacterial profiling method based on the interspace region between the 16S-23S rRNA genes. Detection of operational taxonomic units, the Shannon Diversity Index, sample similarity analyses and Partial Least Squares Discriminant Analysis (PLS-DA) were employed. Staphylococcus epidermidis, Streptococcus pneumoniae/mitis, Propionibacterium acnes, Staphylococcus capitis, Staphylococcus hominis, Bifidobacterium longum, Haemophilus parainfluenzae, Lactobacillus rhamnosus, Bordetella spp., Streptococcus sanguinis, Peptostreptococcus anaerobius, Staphylococcus aureus, Lactococcus lactis, Enterobacter cloacae, and Citrobacter koseri were the most commonly found bacterial species. S. pneumoniae/mitis was significantly more often observed after implantation, whereas P. acnes was significantly less observed after implantation compared with baseline. The relative abundance of S. epidermidis (17%) and S. aureus (19.4%) was the highest for the group of patients with inflammation. The Shannon Diversity Index was significantly increased after implantation compared with pre-surgical swabs for Firmicutes, Actinobacteria, Fusobacteria, Verrucomicrobia (FAFV), but not for other phyla. When combining all phyla, there was no significant increase in the Shannon Diversity Index. The diversity index was similar post-surgically for patients experiencing inflammation and for patients without inflammation. With a supervised classifier (PLS-DA), patients prone to inflammation could be identified at baseline with an accuracy of 91.7%. In addition, PLS-DA could classify post-surgical abutments as non-inflamed or inflamed with an accuracy of 97.7%. This study shows the potential of using IS-proTM to describe and quantify the microbiota associated with the percutaneous BAHS. Furthermore, the results indicate the possibility of an early identification of patients susceptible to adverse skin reaction following implantation. Both S. aureus and S. epidermidis should be considered as relevant bacteria for BAHS-associated inflammation.
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| 3. |
- Calon, T. G. A., et al.
(författare)
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The Use of cone Beam computed Tomography in Assessing the Insertion of Bone conduction hearing Implants
- 2017
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Ingår i: Frontiers in Surgery. - : Frontiers Media SA. - 2296-875X. ; 4
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Tidskriftsartikel (refereegranskat)abstract
- Objective: This study aimed to compare postoperative cone beam CT (CBCT) imaging to implant stability quotient (ISO) measurement and direct caliper measurements as a suitable technique to assess bone conduction hearing implant (BCHI) seating and insertion depth. Methods: in vitro, BCHIs were completely (n = 9) and partially inserted (n = 9) in bone blocks of different densities and subsequently scanned. Scans were processed using 3DSlicer 4.3.1 and Mathematica 10.3. ISO measurements were obtained for all BCHIs mounted with different abutment lengths (9, 12, and 14 mm). CBCT imaging was performed for patients with a clinical indication. Results: In vitro, 95% prediction intervals for partially inserted and completely inserted BCHIs were determined. ISO values significantly decreased with partial insertion, low -density artificial bone, and longer abutment lengths. Evaluation of in vitro and in vivo 3D models allowed for assessment of insertion depth and inclination. Conclusion: CBCT imaging allows to study implant seating and insertion depth after BCHI surgery. This can be useful when visual confirmation is limited. It is possible to distinguish a partial BCHI insertion from a complete insertion in artificial bone blocks. This technique could prove to be a valuable research tool. In vitro, ISO values for Ponto BCHIs relate to abutment length, insertion depth, and artificial bone density.
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| 4. |
- Calon, T. G. A., et al.
(författare)
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Cytokine expression profile in the bone-anchored hearing system: 12-week results from a prospective randomized, controlled study
- 2018
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Ingår i: Clinical Implant Dentistry and Related Research. - : Wiley. - 1523-0899. ; 20:4, s. 606-616
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveTo study the effect of implanting the percutaneous bone-anchored hearing system (BAHS) itself and inflammation of the peri-abutment skin warrant clarification. In this study, we aimed to acquire further insight into the immune responses related to BAHS surgery and peri-implant skin inflammation. Materials and MethodsDuring surgery and 12 weeks post-implantation, skin biopsies were obtained. If applicable, additional biopsies were taken during cases of inflammation. The mRNA expression of IL-1, IL-6, IL-8, TNF, IL-17, IL-10, TGF-ss, MIP-1, MMP-9, TIMP-1, COL11, VEGF-A, FGF-2 TLR-2, and TLR-4 was quantified using qRT-PCR. ResultsThirty-five patients agreed to the surgery and 12-week biopsy. Twenty-two patients had mRNA of sufficient quality for analysis. Ten were fitted with a BAHS using the minimally invasive Ponto surgery technique. Twelve were fitted with a BAHS using the linear incision technique with soft-tissue preservation. Five biopsies were obtained during episodes of inflammation. The post-implantation mRNA expression of IL-1 (P = .002), IL-8 (P = .003), MMP9 (P = .005), TIMP-1 (P= .002), and COL11 (P < .001) was significantly up-regulated. IL-6 (P = .009) and FGF-2 (P=.004) mRNA expression was significantly down-regulated after implantation. Within patients, no difference between post-implantation mRNA expression (at 12 weeks) and when inflammation was observed. Between patients, the expression of IL-1 (P = .015) and IL-17 (P = .02) was higher during cases of inflammation compared with patients who had no inflammation at 12-week follow-up. ConclusionsAs part of a randomized, prospective, clinical trial, the present study reports the molecular profile of selected cytokines in the soft tissue around BAHS. Within the limit of this study, the results showed that 12 weeks after BAHS implantation the gene expression of some inflammatory cytokines (IL-8 and IL-1) is still relatively high compared with the baseline, steady-state, expression. The up-regulation of anabolic (COL11) and tissue-remodeling (MMP-9 and TIMP1) genes indicates an ongoing remodeling process after 12 weeks of implantation. The results suggest that IL-1, IL-17, and TNF- may be interesting markers associated with inflammation.
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