Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.

Study Overview
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Brief Summary
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the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp

Detailed Description
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To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on: - Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation. Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml). Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.

Official Title
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Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial

Conditions
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Necrotic Pulp, Apical Periodontitis

Intervention / Treatment
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* Drug: Diclofenac Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Inclusion criteria: Patients who are free from any physical or mental handicapping condition with no underlying systemic disease. Age between 18-50 years. Males & Females. Mandibular single rooted permanent premolar teeth: Diagnosed clinically with pulp necrosis. Absence of spontaneous pain. Positive pain on percussion denoting apical periodontitis. Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically. Patients' acceptance to participate in the trial. Patients who can understand pain scale and can sign the informed consent Exclusion Criteria: Medically compromised patients Pregnant women. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Patients reporting bruxism or clenching. Teeth that show association with acute periapical abscess and swelling. Greater than grade I mobility or pocket depth greater than 5mm. Non-restorable teeth Teeth with vital pulp. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Interventional Model Description: Trial Design: Randomized Clinical Trial (Parallel Group) Two Arms Allocation Ratio: 1:1 Framework: Superiority
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: calcium hydroxide<br>calcium hydroxide will be placed as intracanal medication between visits. | Drug: Diclofenac Sodium<br>* intracanal medication<br>|
| Active Comparator: diclofenac sodium<br>diclofenac sodium will be placed as intracanal medication between visits | Drug: Diclofenac Sodium<br>* intracanal medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Intensity of postoperative pain | measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation. | 6,12.24.48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load reduction | bacterial counting using agar culture technique after root canal preparation (CFU/ml). | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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necrosis