Oral HealthNCT00299598
Clinical Study of Antibacterial Nanoparticles Incorporated in Composite Restorations
An observational study of Oral Health, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- alkylated polyethylenimine nanoparticles antibacterial evaluation
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: personal of Hadassah MO
Who may be able to join
- must be able to wear upper removable appliance
Who cannot join
- gag reflex
- infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Health
- Being tested
- alkylated polyethylenimine nanoparticles antibacterial evaluation
- Keywords
- antibacterial, composite, polyethylenimine, nanoparticle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alkylated polyethylenimine nanoparticles antibacterial evaluationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ervin I Weiss, DMD, Study chair, Hadassah Medical OrganizationAvi Domb, Phd, Study director, Hebrew University of JerusalemMichael M Perez Davidi, DMD, Principal investigator, Hadssah Medical OrgenizationNurit Beyth, DMD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299598
- Sponsor's protocol ID
- 191060HMO-CTIL
- Status last verified
- Oct 2009
- First submitted
- 5 Mar 2006
- Last updated
- 6 Jan 2010
- Results posted
- No
Publications
Matalon S, Slutzky H, Weiss EI. Surface antibacterial properties of packable resin composites: part I. Quintessence Int. 2004 Mar;35(3):189-93.
PubMed 15119676
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- phase2 Safety and Efficacy of Antibacterial Nano Particles Incorporated in Dental Composite.
- ClinicalTrials.gov ID
- NCT00299598
- Acronym / sponsor ID
- 191060HMO-CTIL
- Conditions
- Oral Health
- Keywords
- antibacterial, composite, polyethylenimine, nanoparticle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- personal of Hadassah MO
Key inclusion criteria (1 listed)
- must be able to wear upper removable appliance
Key exclusion criteria (2 listed)
- gag reflex
- infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alkylated polyethylenimine nanoparticles antibacterial evaluation | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
- Results publication: PubMed 15119676Matalon S, Slutzky H, Weiss EI. Surface antibacterial properties of packable resin composites: part I. Quintessence Int. 2004 Mar;35(3):189-93.
- Michael Perez DavidiLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ervin I Weiss, DMD study chair
Hadassah Medical Organization
Avi Domb, Phd study director
Hebrew University of Jerusalem
Michael M Perez Davidi, DMD principal investigator
Hadssah Medical Orgenization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2010.