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

March 5, 2006
January 5, 2010
September 2006
December 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00299598 on ClinicalTrials.gov Archive Site
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Clinical Study of Antibacterial Nanoparticles Incorporated in Composite Restorations
phase2 Safety and Efficacy of Antibacterial Nano Particles Incorporated in Dental Composite.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

personal of Hadassah MO

Oral Health
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
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Matalon S, Slutzky H, Weiss EI. Surface antibacterial properties of packable resin composites: part I. Quintessence Int. 2004 Mar;35(3):189-93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:healthy

  • must be able to wear upper removable appliance

Exclusion Criteria:

  • gag reflex
  • infectious disease
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00299598
191060HMO-CTIL
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Hadassah Medical Organization
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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
Hadassah Medical Organization
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP