Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299598
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2006-03-05
Brief Title:
Clinical Study of Antibacterial Nanoparticles Incorporated in Composite Restorations
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
phase2 Safety and Efficacy of Antibacterial Nano Particles Incorporated in Dental Composite
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Resin composites withholding antibacterial properties may be useful in preventing recurrent caries Covalently attached antibacterial polymers are a possible solutionThis 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 applianceThe 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
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 ie 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 ww 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
methodsalkylated polyethylenimine PEI nanoparticles added 1 wwto hybrid composite resin disks embedded in a palatal removable applianceThe 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
methodsalkylated polyethylenimine PEI nanoparticles added 1 wwto hybrid composite resin disks embedded in a palatal removable applianceThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None