Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
the study was to evaluate the effect of intra-canal cryotherapy on post-endodontic pain and interleukin-6 expression in teeth with symptomatic apical periodontitis using different irrigation protocols.

Official Title
-----------------
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial

Conditions
-----------------
Symptomatic Periapical Periodontitis

Intervention / Treatment
-----------------
* Other: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior or premolar single canal in single rooted teeth. Patients aged 20 to 50 years. Exclusion Criteria: Patients under anti-inflammatory medication, immune-suppressive chemotherapy or any antibiotic medication for the last 2 months. Pregnant or lactating females. Teeth with endo-perio lesions.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group I (control )<br>irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping, between each file and till the final rinse | |
| Experimental: Group II<br>irrigation with 5% cold sodium hypochlorite (2-5°C) from the beginning of cleaning and shaping and between each file. Final rinse was done by 20 mL of 5% cold sodium hypochlorite (2-5°C) for 5 minutes | Other: Cryotherapy<br>* cold application<br>|
| Experimental: Group III<br>irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping and between each file. Then final rinse with 20 mL of 5% cold sodium hypochlorite (2-5°C) for 5 minutes | Other: Cryotherapy<br>* cold application<br>|
| Experimental: Group IV<br>irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping and between each file. Then final rinse with 20 mL of cold saline (2-5°C) for 5 minutes | Other: Cryotherapy<br>* cold application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN | post-operative pain is measured by using visual analogue scale (VAS) The modified VAS will include a 10 cm straight horizontal line numbered at each centimeter with following criteria: (0) for no pain, (1-3) for mild pain, (4-6) for moderate pain, (7-9) for severe tolerable pain and (10) for severe intolerable pain | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryotherapy, Interleukins, Postoperative pain, Sodium hypochlorite