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

NCT01167985 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-07-23

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Michael Michael Perez Davidi, DMD · Hadassah Medical Organization

  • Ervin Weiss, DMD · Hadassah Medical Organization

  • Itzhak Abramovitz, DMD · Hadassah Medical Organization

  • Dana Kesler Shvero, DMD · Hadassah Medical Organization

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167985 on ClinicalTrials.gov