Effect of the Incoportation of Copper and Zinc Nanoparticles Into Dental Adhesives

NCT03635138 | Unknown DMC

• 1 other identifier: Fondecyt 1170575
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (2)

• To assess antibacterial ( by inhibition of UFC grow of S Mutans count) and Micro tensile bond strengh (

  UFC (Colony Forming Units) of Stretococus Mutans Count (Numbers) , Microtensile bond strength (Mpa)

  baseline - 1 month post restorative procedure

• In vitro and ex vivo evaluation of MMPs' activity ( Units of fluorecense by inmunofloresence antibody compared with control )

  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)

  baseline - 1 month post restorative procedure

Study Arms (2)

Adhesives Cu/Zn nanoparticles doped

EXPERIMENTAL

Adhesive dopped with Zn Oxide + Cu nanoparticles in a ( 5% / 0.2% concentration )

Other: Metal nanoparticles ( O Zn and Cu)

Adhesive control

ACTIVE COMPARATOR

Adhesive conventional

Other: Dental Adhesive pure

Interventions

Metal nanoparticles ( O Zn and Cu) OTHER

Np of OZn nanoparticles mixed with dental adhesive

Adhesives Cu/Zn nanoparticles doped

Dental Adhesive pure OTHER

Dental Adhesive with commercial preparation

Also known as: Dental Adhesive without nanoparticles

Adhesive control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients who do not agree to volunteer for the study

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Eduardo Fernández G

Santiago, Santiago Metropolitan, 7500505, Chile

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Metal Nanoparticles; Copper; Dental Cements; Nanoparticles

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Dental Materials; Biomedical and Dental Materials

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Bottles with a label remarked with 2 letters A and B , same aspect
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Titular

Model Details: Split mouth, 2 premolars restored with 2 dental adhesives , 1 experimental and 1 control

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 17, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)