A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment
IABN
Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
1 other identifier
interventional
200
1 country
1
Brief Summary
The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.We assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 23, 2013
July 1, 2013
1.4 years
June 9, 2010
July 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In vitro evaluation
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.
One month for provisional restoration.
Secondary Outcomes (2)
Radiological evaluation of the root canal sealer
1 year for the root canal sealer.
Clinical and in vitro evaluation of the root canal sealer
1 year for the root canal sealer.
Study Arms (3)
Root canal sealer group+ IABN
EXPERIMENTALDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation
Provisional restoration material+ IABN
EXPERIMENTALDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation
Experimental- Different root canal sealer+ IABN
EXPERIMENTALDevice: alkylated polyethylenimine nanoparticles antibacterial evaluation
Interventions
Patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
Eligibility Criteria
You may qualify if:
- Needs root canal treatment
- For the provisional restoration- molar teeth with class II restoration
- For the provisional restoration-healty/ uninfected teeth
- For the root canal sealer- single root canal
- For root canal sealer-infected teeth
You may not qualify if:
- systemic health problems
- Pregnant women
- The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, Israel
Related Publications (5)
Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.
PMID: 16564083BACKGROUNDSlutsky H, Weiss EI, Lewinstein I, Slutzky S, Matalon S. Surface antibacterial properties of resin and resin-modified dental cements. Quintessence Int. 2007 Jan;38(1):55-61.
PMID: 17216909BACKGROUNDMatalon S, Weiss EI, Gozaly N, Slutzky H. Surface antibacterial properties of compomers. Eur Arch Paediatr Dent. 2006 Sep;7(3):136-41. doi: 10.1007/BF03262554.
PMID: 17140542BACKGROUNDYudovin-Farber I, Beyth N, Nyska A, Weiss EI, Golenser J, Domb AJ. Surface characterization and biocompatibility of restorative resin containing nanoparticles. Biomacromolecules. 2008 Nov;9(11):3044-50. doi: 10.1021/bm8004897. Epub 2008 Sep 27.
PMID: 18821794BACKGROUNDShvero DK, Davidi MP, Weiss EI, Srerer N, Beyth N. Antibacterial effect of polyethyleneimine nanoparticles incorporated in provisional cements against Streptococcus mutans. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):367-371. doi: 10.1002/jbm.b.31662.
PMID: 20583306BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Michael Perez Davidi, DMD
Hadassah Medical Organization
- STUDY CHAIR
Ervin Weiss, DMD
Hadassah Medical Organization
- STUDY CHAIR
Itzhak Abramovitz, DMD
Hadassah Medical Organization
- STUDY CHAIR
Dana Kesler Shvero, DMD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMD
Study Record Dates
First Submitted
June 9, 2010
First Posted
July 22, 2010
Study Start
July 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
July 23, 2013
Record last verified: 2013-07