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

Hadassah Medical Center

Status and phase: Unknown; Phase 2

Conditions: Health Pulp; Infected Pulp; Endodontic Treatment; Irreversible Pulpitis

Treatments: Device: IABN

Study type: Interventional

Funder types: Other

Identifiers

NCT01167985

191062 HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups

Root canal sealer group+ IABN

Experimental group

Description:

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Treatment:

Device: IABN

Device: IABN

Device: IABN

Provisional restoration material+ IABN

Experimental group

Description:

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Treatment:

Device: IABN

Device: IABN

Device: IABN

Experimental- Different root canal sealer+ IABN

Experimental group

Description:

Device: alkylated polyethylenimine nanoparticles antibacterial evaluation

Treatment:

Device: IABN

Device: IABN

Device: IABN