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

Irreversible Pulpitis Clinical Trial

— IABN  

Official title:

Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167985
• Other study ID #: 191062 HMO-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: June 9, 2010
• Last updated: July 20, 2013
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: Hadassah Medical Organization
• Contact: Michael Perez Davidi, DMD
• Phone: 00 972 3 9244859
• Email: michaelperezdavidi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Needs root canal treatment

2. For the provisional restoration- molar teeth with class II restoration

3. For the provisional restoration-healty/ uninfected teeth

4. For the root canal sealer- single root canal

5. For root canal sealer-infected teeth

Exclusion Criteria:

1. systemic health problems

2. Pregnant women

3. The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endodontic Treatment
• Health Pulp
• Infected Pulp
• Irreversible Pulpitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. Epub 2006 Mar 27. — View Citation

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

Shvero 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):367-71. doi: 10.1002/jbm.b.31662. — View Citation

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. — View Citation

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. doi: 10.1021/bm8004897. Epub 2008 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Radiological evaluation of the root canal sealer	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.	1 year for the root canal sealer.	No
Secondary	Clinical and in vitro evaluation of the root canal sealer	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.	1 year for the root canal sealer.	No

External Links

•   Michael Perez Davidi