Clinical trial NCT03998865: Bacterial Microbiota Characterization on Implant-supported PEEK and Titanium Provisional Abutments
Official title: Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Oral Bacterial Infection
Bacterial Resistance
Keywords: Implant-supported Provisional Abutment
Poly-ether-ether-ketone
Titanium
Bacterial Microbiota
Antimicrobial Resistance Genes
Lead sponsor: University of Concepcion, Chile
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in the Number of Operational Taxonomic Units (OTUS)
timeFrame: Baseline (prior to abutment insertion) and two months after abutment insertion.
measure: Changes in Antibacterial Resistance Genes (ARG)
timeFrame: Baseline (prior to abutment insertion) and two months after abutment insertion.
Secondary outcomes:
measure: Changes in the number of bacterial species
timeFrame: Baseline (prior to abutment insertion) and two months after abutment insertion.
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Department of Restorative Dentistry, Faculty of Dentistry, University of Concepcion
state: Bio Bio
Study officials:
affiliation: Department of Restorative Dentistry, University of Concepcion
name: Michael U Wendler, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
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