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Trial record 32 of 10563 for:    Anti-Infective Agents AND Bacterial

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

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ClinicalTrials.gov Identifier: NCT03998865
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Wendler Ernst, University of Concepcion, Chile

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.

Condition or disease Intervention/treatment Phase
Peri-implant Mucositis Oral Bacterial Infection Bacterial Resistance Device: Provisional abutment material Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998865


Contacts
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Contact: Michael U Wendler, DDS, PhD +5641266 ext 1786 mwendler@udec.cl
Contact: Nydia Arias, DDS +5641220 ext 4481 arias.nydia@gmail.com

Locations
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Chile
Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion Recruiting
Concepción, Bio Bio, Chile, 4070369
Contact: Michael U Wendler, DDS, PhD    +5641266 ext 1786    mwendler@udec.cl   
Contact: Nydia Arias, DDS    +5641220 ext 4481    arias.nydia@gmail.com   
Sponsors and Collaborators
Michael Wendler Ernst
Investigators
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Principal Investigator: Michael U Wendler, DDS, PhD Department of Restorative Dentistry, University of Concepcion

Publications:

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Responsible Party: Michael Wendler Ernst, Assistant Professor at the Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion, Chile
ClinicalTrials.gov Identifier: NCT03998865     History of Changes
Other Study ID Numbers: 218.102.032-1.0IN
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Wendler Ernst, University of Concepcion, Chile:
Implant-supported Provisional Abutment
Poly-ether-ether-ketone
Titanium
Bacterial Microbiota
Antimicrobial Resistance Genes
Additional relevant MeSH terms:
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Bacterial Infections
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents