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

NCT03998865 | Completed

• 1 other identifier: 218.102.032-1.0IN
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-implant Mucositis; Oral Bacterial Infection; Bacterial Resistance

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Changes in the number of bacterial species

  Baseline (prior to abutment insertion) and two months after abutment insertion.

Study Arms (2)

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.

Device: Provisional abutment material

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.

Device: Provisional abutment material

Interventions

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.

PEEK Provisional Abutment; Titanium Provisional Abutment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Immunosuppressed patients
• Tabacco, alcohol or drug addictions
• History of periodontal disease
• Need of bone grafting in the implant region

Sponsors & Collaborators

• Michael Wendler Ernst: lead

Study Sites (1)

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

Concepción, Bio Bio, 4070369, Chile

Location

Related Publications (12)

• 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.

  PMID: 27434650 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.

  PMID: 25385682 BACKGROUND

• 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.

  PMID: 19374709 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.

  PMID: 12598555 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.

  PMID: 19885401 BACKGROUND

• 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.

  PMID: 16364434 BACKGROUND

• 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.

  PMID: 25195711 BACKGROUND

• 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.

  PMID: 23622745 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.

  PMID: 16537105 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.

  PMID: 9765804 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.

  PMID: 22520388 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.

  PMID: 29786880 BACKGROUND

Study Officials

• Michael U Wendler, DDS, PhD

  Department of Restorative Dentistry, University of Concepcion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor at the Department of Restorative Dentistry, Faculty of Dentistry

Model Details: 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).

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 26, 2019
• Study Start: May 8, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)