Clinical Study of Antibacterial Nanoparticles Incorporated in Composite Restorations

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00299598
First received: March 5, 2006
Last updated: January 5, 2010
Last verified: October 2009
  Purpose

Resin composites withholding antibacterial properties may be useful in preventing recurrent caries. Covalently attached antibacterial polymers are a possible solution.This in vivo study would evaluated the antibacterial effect of alkylated polyethylenimine nanoparticles incorporated into flowable and hybrid composite resin disks embedded in a palatal removable appliance.The disks would be in close contact with the palate in order to check for contact mucosities. disks on the side facing the Tongue would be evaluated for their antibacterial potency with confocal laser scanning microscopy.


Condition Intervention Phase
Oral Health
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: phase2 Safety and Efficacy of Antibacterial Nano Particles Incorporated in Dental Composite.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Enrollment: 10
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Composite resin materials are widely used in the dental clinic for replacement of hard tissues. Although the mechanical properties and wear resistance of these materials have been improved substantially, their antibacterial properties are still limited. These resin-based materials accumulate more dental plaque than other restorative materials both in vitro, and in vivo, which may result in secondary caries. A number of reports described experiments in which composite resins were impregnated with antibacterial agents such as antibiotics, silver ions, iodine and quaternary ammonium compounds, and gradually released them. However, release of antibacterial agents into the surrounding milieu at various releasing rates had several disadvantages: a decrease in the mechanical properties of the carrier material over time, short-term effectiveness, and possible toxicity if the release is not properly controlled. As compared with conventional antibacterial agents of low molecular weight, the advantage of polymeric antibacterial agents is that they are nonvolatile, chemically stable, can be chemically bound within the polymer carrier via active groups for improved integration in the composite, and are difficult to penetrate through the skin. It has been reported that polycations exhibit antibacterial properties, i.e. interact with and disrupt bacterial cell membranes. A number of polymers with antibacterial properties were developed for this purpose, including soluble and insoluble pyridinium-type polymers involved in surface coating. Several reports have described incorporation of a methacryloyloxydodecylpydidinium bromide (MDPB) monomer in composite resins that showed no release of the incorporated monomer but still exhibited antibacterial properties. The objective of this study is to evaluate clinically the safety and efficacy of alkylated polyethylenimine (PEI) nanoparticles in composite resin restorative materials . In an in vitro study, addition of a small percent (1% w/w) of nanoparticles did not affect significantly the flexural strength of the commercial materials. The mechanical properties of the new composites were close to those of the original composite, but exerted a strong antibacterial activity upon contact that lasted for at least six months.

methods:alkylated polyethylenimine (PEI) nanoparticles added (1% w/w)to hybrid composite resin disks embedded in a palatal removable appliance.The disks would be in close contact with the palate in order to check for contact mucosities. disks on the side facing the Tongue would be evaluated for their antibacterial potency with confocal laser scanning microscopy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

personal of Hadassah MO

Criteria

Inclusion Criteria:healthy

  • must be able to wear upper removable appliance

Exclusion Criteria:

  • gag reflex
  • infectious disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00299598

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Chair: Ervin I Weiss, DMD Hadassah Medical Organization
Study Director: Avi Domb, Phd Hebrew University of Jerusalem
Principal Investigator: Michael M Perez Davidi, DMD Hadssah Medical Orgenization
Principal Investigator: Nurit Beyth, DMD Hadassah Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00299598     History of Changes
Other Study ID Numbers: 191060HMO-CTIL
Study First Received: March 5, 2006
Last Updated: January 5, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
antibacterial
composite
polyethylenimine
nanoparticle

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014