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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endodontic Treatment, Irreversible Pulpitis, Health Pulp, Infected Pulp

Intervention / Treatment
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* Device: IABN
* Device: IABN
* Device: IABN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Root canal sealer group+ IABN<br>Device: alkylated polyethylenimine nanoparticles antibacterial evaluation | Device: IABN<br>* 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.<br>* Other names: QA-PEI;|
| Experimental: Provisional restoration material+ IABN<br>Device: alkylated polyethylenimine nanoparticles antibacterial evaluation | Device: IABN<br>* 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.<br>* Other names: QA-PEI;|
| Experimental: Experimental- Different root canal sealer+ IABN<br>Device: alkylated polyethylenimine nanoparticles antibacterial evaluation | Device: IABN<br>* 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.<br>* Other names: QA-PEI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month for provisional restoration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year for the root canal sealer. | 
| 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. | 1 year for the root canal sealer. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibacterial polyethyleneimine nanoparticles, quaternary ammonium, dental, Endodotnic, pulp, bacteria, Root canal sealer, temporary filling, provisional restoration