Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp

Study Overview
=================
Brief Summary
-----------------
To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on: Intensity of postoperative pain. Bacterial load reduction. levels of MMP -9 in Periapical Fluids.

Official Title
-----------------
Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial

Conditions
-----------------
Intracanal Medication, N-acetylcystine, Calcium Hydroxide, Mediators

Intervention / Treatment
-----------------
* Drug: N-acetyl cysteine
* Drug: Calcium hydroxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are free from any physical or mental handicapping condition. Males & Females with Mandibular single rooted permanent premolar teeth. Absence of spontaneous pain. 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 (Appendix I) Exclusion Criteria: Medically compromised patients. Pregnant women Patients undergoing previous endodontic treatment or analgesics and/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 or teeth that could not be adequately isolated with a rubber dam Teeth with vital pulp. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>intracanal medication of NAC paste | Drug: N-acetyl cysteine<br>* intracanal medication of NAC with concentration 1 gm/ml in the form of a paste<br>|
| Active Comparator: Calcium hydroxide<br>intracanal medication of Ca(OH)2 paste | Drug: Calcium hydroxide<br>* intracanal medication of calcium hydroxide paste (metapaste)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 6 hours post-instrumentation. | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 12 hours post-instrumentation | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 24 hours post-instrumentation | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 48 hours post-instrumentation | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 6 hours post-obturation. | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 12 hours post-obturation | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 24 hours post-obturation | 
| Intensity of postoperative pain | Intensity of postoperative pain will be measured using numerical rating scale (NRS) | 48 hours post-obturation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial load reduction | Bacterial counting using agar Culture technique | Sample 1 (S1): after access preparation and pre-instrumentation. | 
| Bacterial load reduction | Bacterial counting using agar Culture technique | Sample 2 (S2): at the end of 1st visit post-instrumentation. | 
| Bacterial load reduction | Bacterial counting using agar Culture technique | Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation) | 
| Periapical MMP-9 level | using ELISA | at 1st visit post- instrumentation. | 
| Periapical MMP-9 level | using ELISA | after 2 weeks at 2nd visit (pre-obturation). |