Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction.

Detailed Description
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Clinical compare the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction when used as root canal irrigant in necrotic pulp. The post operative pain will be recorded using Numerical rating scale, and the bacterial load reduction will be measured by Bacterial counting using agar culture technique.

Official Title
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Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp

Conditions
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Necrotic Pulp, Post Operative Pain

Intervention / Treatment
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* Other: Vachellia Nelotica
* Other: sodium hypochlorite


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Systemically healthy patient (ASA I, II). Age between 20 and 40 years. Male or female. Patient who is able to sign and comprehend the pain scale (committed patient). Mandibular single rooted premolars having the following criteria: With single root canal. Diagnosed clinically with pulp necrosis. Absence of spontaneous pulpal pain. Positive pain on percussion denoting apical periodontitis. Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm). Exclusion criteria: Medically compromised patients (ASA III or IV). 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 will be also excluded. History of intolerance to NSAIDs.

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 |
| --- | --- |
| Active Comparator: Control group<br>in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard) | Other: sodium hypochlorite<br>* As a root canal irrigant<br>|
| Experimental: Experimental group<br>in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant) | Other: Vachellia Nelotica<br>* As a root canal irrigant (herbal)<br>* Other names: Babul;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain. | non=0, mild=1-3, moderate4-6, sever=7-10. Measured and reported by Numerical Rating Scale (NRS). Minimum value=0, maximum value=10, the higher score or value mean a worse outcome. | At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load reduction | Bacterial counting using agar culture technique. | 1 hour. First sample (S1) will be taken pre-intervention (before chemo-mechanical preparation) and the second sample (S2) will be taken immediately after the intervention (after completion of chemo-mechanical preparation) on the same visit. |