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The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
The use of provisional abutments is mandatory during the restorative phase of any implant based oral rehabilitation. The introduction of poly-ether-ether-ketone (PEEK) for the manufacturing of provisional abutments as an alternative to conventional titanium abutments has opened the restorative spectra, offering the clinician and the patient better aesthetics and adhesive outcomes than its predecessor. However, there is to date no clarity on the impact of PEEK on the bacterial growth and the specificity of the microbiota on the abutment surface. Therefore, the present study aims to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK and titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Study Hypotheses:
The study uses a metagenomic approach based on the characterization of the bacterial communities, as well as on the sequencing of the 16S gene, and on the other hand, on the sequencing of the high-throughput (HTS) of the whole genome, for variations of the antibiotic resistance genes.
Sample retrieval will be conducted prior to implant placement, at the adjacent teeth gingival sulcus (t0), and two months after provisional abutment (and crown) connection (t1), from the retrieved abutments. Patient allocation in the "PEEK" or "Titanium" groups will be randomized. Intra- and interpatient comparisons will be conducted. Statistical analyses include two-way ANOVA and Tukey's post-hoc test, at p<0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK Provisional Abutment | Experimental | The provisional crown will be fixed onto a PEEK abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. |
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| Titanium Provisional Abutment | Active Comparator | The provisional crown will be fixed onto a titanium abutment and then connected to the implant. The bis-acrylic resin used for the provisional crown will not invade the emergence profile of the abutment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provisional abutment material | Device | The effect of the provisional abutment material on the characteristics of the bacterial microbiota will be assessed by using PEEK (experimental) or Titanium (active comparator) provisional abutments. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Number of Operational Taxonomic Units (OTUS) | Changes in the Number of Operational Taxonomic Units (OTUS) observed after the two months evaluation period will be assessed using UniFrac metrics. The weighted UniFrac distances will be used to perform a principal coordinate analysis (PCO). | Baseline (prior to abutment insertion) and two months after abutment insertion. |
| Changes in Antibacterial Resistance Genes (ARG) | Changes in the ARG of the microbiota will be determined using the whole genome sequencing using the MiSeq Illumina method. | Baseline (prior to abutment insertion) and two months after abutment insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the number of bacterial species | Changes in the bacterial microbiota richness will be evaluated using a bias corrected Chao 1 richness estimator and the Shannon diversity index. | Baseline (prior to abutment insertion) and two months after abutment insertion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael U Wendler, DDS, PhD | Department of Restorative Dentistry, University of Concepcion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion | Concepción | Biobio | 4070369 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27434650 | Background | Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, Muller WD. The applicability of PEEK-based abutment screws. J Mech Behav Biomed Mater. 2016 Oct;63:244-251. doi: 10.1016/j.jmbbm.2016.06.024. Epub 2016 Jul 1. | |
| 25385682 | Background | Mawhinney J, Connolly E, Claffey N, Moran G, Polyzois I. An in vivo comparison of internal bacterial colonization in two dental implant systems: identification of a pathogenic reservoir. Acta Odontol Scand. 2015 Apr;73(3):188-94. doi: 10.3109/00016357.2014.978365. Epub 2014 Nov 11. |
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No individual participant data will be communicated, in accordance with the ethical approval of the study. Data will be communicated grouped with the individual effects on the results assessed with the respective statistical tools.
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Participants will be randomly assigned to one of two groups: PEEK or Titanium provisional-abutments. A sample of the niche microbiota will be retrieved prior to implant placement (t0) and two months after provisional abutment (crown) connection (t1).
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Participants will be not aware of the type of provisional abutment used in their treatment. Retrieved samples will be codified in order to mask them for the metagenomic analysis.
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| 12598555 | Background | Broggini N, McManus LM, Hermann JS, Medina RU, Oates TW, Schenk RK, Buser D, Mellonig JT, Cochran DL. Persistent acute inflammation at the implant-abutment interface. J Dent Res. 2003 Mar;82(3):232-7. doi: 10.1177/154405910308200316. |
| 19885401 | Background | Subramani K, Jung RE, Molenberg A, Hammerle CH. Biofilm on dental implants: a review of the literature. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):616-26. |
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| 16537105 | Background | Baker-Austin C, Wright MS, Stepanauskas R, McArthur JV. Co-selection of antibiotic and metal resistance. Trends Microbiol. 2006 Apr;14(4):176-82. doi: 10.1016/j.tim.2006.02.006. Epub 2006 Mar 14. |
| 9765804 | Background | Di Cello F, Pepi M, Baldi F, Fani R. Molecular characterization of an n-alkane-degrading bacterial community and identification of a new species, Acinetobacter venetianus. Res Microbiol. 1997 Mar-Apr;148(3):237-49. doi: 10.1016/S0923-2508(97)85244-8. |
| 22520388 | Background | Diaz PI, Dupuy AK, Abusleme L, Reese B, Obergfell C, Choquette L, Dongari-Bagtzoglou A, Peterson DE, Terzi E, Strausbaugh LD. Using high throughput sequencing to explore the biodiversity in oral bacterial communities. Mol Oral Microbiol. 2012 Jun;27(3):182-201. doi: 10.1111/j.2041-1014.2012.00642.x. Epub 2012 Mar 3. |
| 29786880 | Background | Sanchez-Sanhueza G, Bello-Toledo H, Gonzalez-Rocha G, Goncalves AT, Valenzuela V, Gallardo-Escarate C. Metagenomic study of bacterial microbiota in persistent endodontic infections using Next-generation sequencing. Int Endod J. 2018 Dec;51(12):1336-1348. doi: 10.1111/iej.12953. Epub 2018 Jun 9. |