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

NCT ID: NCT03998865

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2019-12-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peri-implant Mucositis Oral Bacterial Infection Bacterial Resistance

Keywords

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Implant-supported Provisional Abutment Poly-ether-ether-ketone Titanium Bacterial Microbiota Antimicrobial Resistance Genes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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PEEK Provisional Abutment

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.

Group Type EXPERIMENTAL

Provisional abutment material

Intervention Type 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.

Titanium Provisional Abutment

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.

Group Type ACTIVE_COMPARATOR

Provisional abutment material

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michael Wendler Ernst

OTHER

Sponsor Role lead

Responsible Party

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Michael Wendler Ernst

Assistant Professor at the Department of Restorative Dentistry, Faculty of Dentistry

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael U Wendler, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Restorative Dentistry, University of Concepcion

Locations

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Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion

Concepción, Bio Bio, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type BACKGROUND
PMID: 27434650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25385682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19374709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12598555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19885401 (View on PubMed)

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. doi: 10.1016/j.biomaterials.2005.11.044. Epub 2005 Dec 20.

Reference Type BACKGROUND
PMID: 16364434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25195711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23622745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16537105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9765804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22520388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29786880 (View on PubMed)

Other Identifiers

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218.102.032-1.0IN

Identifier Type: -

Identifier Source: org_study_id