Clinical trial NCT00299598: Clinical Study of Antibacterial Nanoparticles Incorporated in Composite Restorations
Official title: phase2 Safety and Efficacy of Antibacterial Nano Particles Incorporated in Dental Composite.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Health
Keywords: antibacterial
composite
polyethylenimine
nanoparticle
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-03-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: personal of Hadassah MO

Brief summary: 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.

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 criteria: Inclusion Criteria:healthy

* must be able to wear upper removable appliance

Exclusion Criteria:

* gag reflex
* infectious disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ervin I Weiss, DMD
role: STUDY_CHAIR
affiliation: Hebrew University of Jerusalem
name: Avi Domb, Phd
role: STUDY_DIRECTOR
affiliation: Hadssah Medical Orgenization
name: Michael M Perez Davidi, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Nurit Beyth, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matalon S, Slutzky H, Weiss EI. Surface antibacterial properties of packable resin composites: part I. Quintessence Int. 2004 Mar;35(3):189-93.