Bacterial Microbiota Characterization on Implant-supported PEEK and Titanium Provisional Abutments

Peri-implant Mucositis Clinical Trial

Official title:

Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998865
• Other study ID #: 218.102.032-1.0IN
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: University of Concepcion, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

• H1: The characteristics of the bacterial microbiota present at the connection area of implant-supported provisional abutments are dependent upon the abutment material.

• H2: An increased presence of antibiotic resistance genes is found in the bacterial microbiota on titanium provisional abutments when compared to that found on PEEK abutments.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ASA I patients

• Indication of implant treatment to replace an upper or lower premolar

• Presence of natural teeth adjacent to the implant region

• Gingival biotype in the posterior region of 3 to 4 mm

Exclusion Criteria:

• Immunosuppressed patients

• Tabacco, alcohol or drug addictions

• History of periodontal disease

• Need of bone grafting in the implant region

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterial Resistance
• Mucositis
• Oral Bacterial Infection
• Peri-implant Mucositis

Intervention

Device:
• Provisional abutment material
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.

Locations

Country	Name	City	State
Chile	Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion	Concepción	Bio Bio

Sponsors (1)

Lead Sponsor	Collaborator
Michael Wendler Ernst

Country where clinical trial is conducted

Chile, 

References & Publications (12)

Baker-Austin C, Wright MS, Stepanauskas R, McArthur JV. Co-selection of antibiotic and metal resistance. Trends Microbiol. 2006 Apr;14(4):176-82. Epub 2006 Mar 14. Review. — View Citation

Barbosa RE, do Nascimento C, Issa JP, Watanabe E, Ito IY, de Albuquerque RF Jr. Bacterial culture and DNA Checkerboard for the detection of internal contamination in dental implants. J Prosthodont. 2009 Jul;18(5):376-81. doi: 10.1111/j.1532-849X.2009.00454.x. Epub 2009 Apr 3. — View Citation

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. — View Citation

Campoccia D, Montanaro L, Arciola CR. The significance of infection related to orthopedic devices and issues of antibiotic resistance. Biomaterials. 2006 Apr;27(11):2331-9. Epub 2005 Dec 20. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Romanos GE, Biltucci MT, Kokaras A, Paster BJ. Bacterial Composition at the Implant-Abutment Connection under Loading in vivo. Clin Implant Dent Relat Res. 2016 Feb;18(1):138-45. doi: 10.1111/cid.12270. Epub 2014 Sep 5. — View Citation

Sánchez-Sanhueza G, Bello-Toledo H, González-Rocha G, Gonçalves AT, Valenzuela V, Gallardo-Escárate 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. — View Citation

Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, Müller 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. — View Citation

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. Review. — View Citation

Weber DJ, Rutala WA. Self-disinfecting surfaces: review of current methodologies and future prospects. Am J Infect Control. 2013 May;41(5 Suppl):S31-5. doi: 10.1016/j.ajic.2012.12.005. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.