A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment - Full Text View

Purpose

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.

Condition	Intervention	Phase
Endodontic Treatment Irreversible Pulpitis Health Pulp Infected Pulp	Device: IABN	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

In vitro evaluation [ Time Frame: One month for provisional restoration. ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Radiological evaluation of the root canal sealer [ Time Frame: 1 year for the root canal sealer. ] [ Designated as safety issue: No ]
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.
Clinical and in vitro evaluation of the root canal sealer [ Time Frame: 1 year for the root canal sealer. ] [ Designated as safety issue: No ]
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.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.

Estimated Enrollment:	200
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Root canal sealer group+ IABN Device: alkylated polyethylenimine nanoparticles antibacterial evaluation	Device: IABN 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. Other Name: QA-PEI
Experimental: Provisional restoration material+ IABN Device: alkylated polyethylenimine nanoparticles antibacterial evaluation	Device: IABN patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with and without nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol. Other Name: QA-PEI
Experimental: Experimental- Different root canal sealer+ IABN Device: alkylated polyethylenimine nanoparticles antibacterial evaluation	Device: IABN 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. Other Name: QA-PEI

Detailed Description:

patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
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. Two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. The control group (40 patients) will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.While preparing the post, a small example of the sealer will be taken to a test in the lab.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

systemic health problems
Pregnant women
The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167985

Contacts

Contact: Michael Perez Davidi, DMD	00 972 3 9244859	michaelperezdavidi@gmail.com
Contact: Dana Kesler Shvwero, DMD	00 972 77 2003172	danakesler@gmail.com

Locations

Israel
Hadassah Medical Organization	Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukhert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

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

More Information

Additional Information:

Michael Perez Davidi This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2006 Mar 27.

Slutsky 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.

Matalon S, Weiss EI, Gozaly N, Slutzky H. Surface antibacterial properties of compomers. Eur Arch Paediatr Dent. 2006 Sep;7(3):136-41.

Yudovin-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. Epub 2008 Sep 27.

Responsible Party:	Dr. Perez Davidi Michael, Organization: Hadassah Medical Centers
ClinicalTrials.gov Identifier:	NCT01167985 History of Changes
Other Study ID Numbers:	191062 HMO-CTIL
Study First Received:	June 9, 2010
Last Updated:	November 19, 2012
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

antibacterial polyethyleneimine nanoparticles
quaternary ammonium
dental
Endodotnic
pulp

bacteria
Root canal sealer
temporary filling
provisional restoration

Additional relevant MeSH terms:

Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013