Effect of Moringa Oleifera Leaf Extract 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 Moringa oleifera leaf 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 Moringa Oleifera Leaf Extract 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: Moringa oleifera leaf
* 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 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: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moringa oleifera<br> | Dietary Supplement: Moringa oleifera leaf<br>* Leaf extract preparation<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. | First sample is taken at Time 0 T0 then second sample taken after chemo-mechanical preparation on 15 minutes at Time 1 T1. |