Trial record 5 of 7 for:    Open Studies | "Root Canal Therapy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Perez Davidi Michael, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01167985
First received: June 9, 2010
Last updated: July 20, 2013
Last verified: July 2013
  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:


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: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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:
  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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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:
Publications:
Responsible Party: Perez Davidi Michael, DMD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01167985     History of Changes
Other Study ID Numbers: 191062 HMO-CTIL
Study First Received: June 9, 2010
Last Updated: July 20, 2013
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 July 20, 2014