Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars.

Detailed Description
-----------------
The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical and dental history was obtained from all participants in this trial and clinical and radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or without apical periodontitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (irrigation using 1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment was performed with a week interval in between visits. Each patient received a 7-day diary to record postoperative pain and rescue medication intake. Post-operative pain was measured at the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and postobturation.

Official Title
-----------------
Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

Conditions
-----------------
Dental Pulp Necrosis

Intervention / Treatment
-----------------
* Other: 1.3% NaOCl
* Other: 5.25% NaOCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 25-45 year old. Medically free. Non-vital mandibular teeth (first or second molar) with or without apical periodontitis No sex predilection Exclusion Criteria: Pregnant females. History of allergy to any medication used in the study. Preoperative premedication 12 hours before procedure. Acute abscess cases. Badly-decayed crown. Retreatment cases

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.3% NaOCl<br>Root canal irrigation done using 1.3% NaOCl. | Other: 1.3% NaOCl<br>* Endodontic irrigant<br>* Other names: 1.3% sodium hypochlorite;|
| Active Comparator: 5.25% NaOCl<br>Root canal irrigation done using 5.25% NaOCl. | Other: 5.25% NaOCl<br>* Endodontic irrigant<br>* Other names: 5.25% sodium hypochlorite;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit | immediately after treatment | 
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit | 3 hours | 
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit | 24 hours | 
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit | 48 hours | 
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit | 7 days | 
| Postoperative pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation. | immediately after obturation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sham medication intake incidence | Sham medication intake incidence (Yes/No) taken as an initial rescue medication in case of postoperative pain. | 7 days | 
| Analgesic medication intake incidence | Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake. | 7 days |