search
Back to results

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

Primary Purpose

Endodontic Treatment, Irreversible Pulpitis, Health Pulp

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
IABN
IABN
IABN
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Treatment focused on measuring antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling, provisional restoration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hadassah Medical OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Root canal sealer group+ IABN

Provisional restoration material+ IABN

Experimental- Different root canal sealer+ IABN

Arm Description

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 9, 2010
Last Updated
July 20, 2013
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT01167985
Brief Title
A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment
Acronym
IABN
Official Title
Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Treatment, Irreversible Pulpitis, Health Pulp, Infected Pulp
Keywords
antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling, provisional restoration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Root canal sealer group+ IABN
Arm Type
Experimental
Arm Description
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
Arm Title
Provisional restoration material+ IABN
Arm Type
Experimental
Arm Description
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
Arm Title
Experimental- Different root canal sealer+ IABN
Arm Type
Experimental
Arm Description
Device: alkylated polyethylenimine nanoparticles antibacterial evaluation
Intervention Type
Device
Intervention Name(s)
IABN
Other Intervention Name(s)
QA-PEI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IABN
Other Intervention Name(s)
QA-PEI
Intervention 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 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.
Intervention Type
Device
Intervention Name(s)
IABN
Other Intervention Name(s)
QA-PEI
Intervention Description
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.
Primary Outcome Measure Information:
Title
In vitro evaluation
Description
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.
Time Frame
One month for provisional restoration.
Secondary Outcome Measure Information:
Title
Radiological evaluation of the root canal sealer
Description
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.
Time Frame
1 year for the root canal sealer.
Title
Clinical and in vitro evaluation of the root canal sealer
Description
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.
Time Frame
1 year for the root canal sealer.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Perez Davidi, DMD
Phone
00 972 3 9244859
Email
michaelperezdavidi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Kesler Shvwero, DMD
Phone
00 972 77 2003172
Email
danakesler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Michael Perez Davidi, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ervin Weiss, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Itzhak Abramovitz, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dana Kesler Shvero, DMD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Chair
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukhert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
16564083
Citation
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.
Results Reference
background
PubMed Identifier
17216909
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.
Results Reference
background
PubMed Identifier
17140542
Citation
Matalon 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.
Results Reference
background
PubMed Identifier
18821794
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.
Results Reference
background
PubMed Identifier
20583306
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):367-371. doi: 10.1002/jbm.b.31662.
Results Reference
background
Links:
URL
http://www.mypd.co.il
Description
Michael Perez Davidi

Learn more about this trial

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

We'll reach out to this number within 24 hrs