NCT03998865

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Michael Wendler Ernst · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Peri-implant Mucositis
• Oral Bacterial Infection
• Bacterial Resistance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-08
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2019-06-26
• Last updated: 2019-12-20

Locations

1 site across 1 country: Chile