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Clinical Trials/NCT01167985
NCT01167985
Unknown
Phase 2

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

Hadassah Medical Organization1 site in 1 country200 target enrollmentJuly 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Endodontic Treatment
Sponsor
Hadassah Medical Organization
Enrollment
200
Locations
1
Primary Endpoint
In vitro evaluation
Last Updated
12 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Perez Davidi Michael

DMD

Hadassah Medical Organization

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

Outcomes

Primary Outcomes

In vitro evaluation

Time Frame: One month for provisional restoration.

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 Outcomes

  • 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 Sites (1)

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