Effect of the Incoportation of Copper and Zinc Nanoparticles Into Dental Adhesives on Their Antimicrobial Properties and Dentinal Matrix Metalloproteinases Activity: From Molecular Basis to Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- To assess antibacterial ( by inhibition of UFC grow of S Mutans count) and Micro tensile bond strengh (
Study Overview
Brief Summary
The hypothesis is that Addition of copper or zinc nanoparticles to a dental adhesive confers antimicrobial and enzymatic degradation-resistant properties, retaining its adhesion mechanical properties and biocompatibility. To corroborate this hypothesis two groups of a dental adhesive doped with copper or zinc nanoparticles should be develop with a respective structural characterization by SEM-EDX, AFM and FTIR. This should be followed by a test of the antimicrobial activity of adhesive and a study of the influence of adhesive nanocomposites on matrix metalloproteases levels and/or activity in vitro to determine some concentrations more relevant. These would proceed to next stage. With the selected adhesive doped concentrations should be evaluate mechanical properties of doped adhesives and assess the biocompatibility by assays in primary cultured gingival fibroblast and cells type odontoblasts. Finally, once the concentration of either Cu- or Zn-doped adhesives is known, these will be evaluated with a clinical design phase in an in vivo model to study antimicrobial properties, matrix metaloproteases levels and/or activity. We will also study biocompatibility of adhesive nanocomposites and mechanical properties to corroborate the in vitro and ex vivo properties determined. There are results using copper nanoparticle on biomaterials that corroborates some properties such as antimicrobial activity against various species and copper release. All the evidence suggests that at low concentrations of copper nanoparticles, there are no significant effects on mechanical properties but with added antibacterial properties on the adhesive
Detailed Description
General Objective To evaluate the influence of the incorporation of copper or zinc nanoparticles into a dental adhesive on its antimicrobial action and their influence on dentin matrix metalloproteases activity. To analyze adhesive mechanical properties and biocompatibility Specifics Objectives
- To develop and structurally characterize a dental adhesive doped with copper or zinc nanoparticles.
1.1. Preparation of adhesive nanocomposites; 1.2. Structural characterization of adhesive nanocomposites. 2. To assess mechanical, biochemical and functional effects of adhesive nanocomposites in vitro. Assays will be addressed comparing addition of control adhesive, or the adhesive doped with either copper or zinc on fresh recent extracted teeth.(ex vivo phase) 2.1. To test the antimicrobial activity of adhesive; 2. 2. To study the influence of adhesive nanocomposites on matrix metalloproteases levels and/or activity;2.3. To evaluate mechanical properties of adhesive;2.4. To assess biocompatibility. Viability assays in primary cultured gingival fibroblast will be addressed. 3. To evaluate in vivo model (clinical phase) antimicrobial properties, matrix metalloproteases and cathepsin B levels and/or activity, biocompatibility of adhesive nanocomposites in vivo and mechanical properties. Premolars indicated for extraction will be restored using either traditional adhesive or the adhesive nanocomposite. After a month, premolars will be extracted and analyzed as described.
3.1. To determine surface antimicrobial properties of adhesive nanocomposites; 3.2. To assess matrix metalloproteases and cathepsin B levels and/or activity in dentin tissue macerated;3.3 To determine biocompatibility. Dental pulp will be obtained from extracted premolars, and molecular markers of cell viability or cell damage will be addressed of adhesive nanocomposites;3.4 To evaluate mechanical properties of adhesive.
METHODS
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Bottles with a label remarked with 2 letters A and B , same aspect
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •treatment plans indicating premolar extractions for orthodontic reasons,
- •presence of healthy, intact, non-carious, non-restored, and fully erupted treatment teeth,
- •patients having well-controlled health conditions that allow all procedures to be performed in the research with minimal risk
Exclusion Criteria
- •patients who do not agree to volunteer for the study
- •patients not meeting all of the inclusion criteria
Arms & Interventions
Adhesives Cu/Zn nanoparticles doped
Adhesive dopped with Zn Oxide + Cu nanoparticles in a ( 5% / 0.2% concentration )
Intervention: Metal nanoparticles ( O Zn and Cu) (Other)
Adhesive control
Adhesive conventional
Intervention: Dental Adhesive pure (Other)
Outcomes
Primary Outcomes
To assess antibacterial ( by inhibition of UFC grow of S Mutans count) and Micro tensile bond strengh (
Time Frame: baseline - 1 month post restorative procedure
UFC (Colony Forming Units) of Stretococus Mutans Count (Numbers) , Microtensile bond strength (Mpa)
In vitro and ex vivo evaluation of MMPs' activity ( Units of fluorecense by inmunofloresence antibody compared with control )
Time Frame: baseline - 1 month post restorative procedure
To Assess Matrix Metallopeptidase 2 , 8 and 9 activity by in vitro test and ex vivo (Luminicense units compared vs controls of fluorecence) ( dentin powder obtained fron teeth donated)
Secondary Outcomes
No secondary outcomes reported
Investigators
Eduardo Fernandez
Profesor Titular
University of Chile