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

December 18, 2019 updated by: Michael Wendler Ernst

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Bio Bio
      • Concepción, Bio Bio, Chile, 4070369
        • Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Number of Operational Taxonomic Units (OTUS)
Time Frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
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)
Time Frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the number of bacterial species
Time Frame: Baseline (prior to abutment insertion) and two months after abutment insertion.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Wendler Ernst

Investigators

  • Principal Investigator: Michael U Wendler, DDS, PhD, Department of Restorative Dentistry, University of Concepcion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2019

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

June 12, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218.102.032-1.0IN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Bacterial Infection

Clinical Trials on Provisional abutment material

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe