Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars

Study Overview
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Brief Summary
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The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

Official Title
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Effect Of Propolis Nanoparticles Versus Sodium Hypochlorite As Root Canal Irrigant On Postoperative Pain And Bacterial Reduction In Mandibular Premolars With Necrotic Pulps (A Randomized Clinical Trial)

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Dietary Supplement: Propolis nanoparticles extract solution
* Drug: sodium hypochlorite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systematically healthy patient (ASA I,II). Age between 20 and 55 years Male or female. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis. Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency. Exclusion Criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). History of intolerance to NSAIDS. Teeth with: Immature roots Vital pulp tissues. Association with swelling. Acute peri-apical abscess or acute exacerbation of a chronic abscess. Mobility Grade II or III. Previously accessed or endodontically treated Deep periodontal pockets more than 4 mm Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions. Patients who could not interpret the NRS. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis nanoparticles extract solution<br> | Dietary Supplement: Propolis nanoparticles extract solution<br>* 20 mg/ml propolis nanoparticles in the form of solution prepared from honeybee from various plants.<br>|
| Active Comparator: sodium hypochlorite<br> | Drug: sodium hypochlorite<br>* 2.5% sodium hypochlorite (household bleaching agent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: reading represents no pain 1-3: readings represent mild pain 4-6: readings represent moderate pain 7-10: readings represent severe pain | up to 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracanal bacterial load change | The intracanal bacterial load change will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation. | Throughout the chemo-mechanical preparation of the canal. | 
| Number of analgesic tablets taken by the patient after endodontic treatment |  | Up to 48 hours postoperative. |