Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.

Detailed Description
-----------------
Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.

Official Title
-----------------
Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.

Conditions
-----------------
Endodontically Treated Teeth

Intervention / Treatment
-----------------
* Device: TruNatomy Files
* Device: HyFlex EDM Files


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 25 - 45 years old. Males or Females. Mandibular molar teeth with: No pain. No response to pulp testing. Radiographic appearance with or without a periapical radiolucency. Exclusion Criteria: Patients with pre-operative pain. Patients having significant systemic disorders. Patients who are allergic to non-steroidal anti-inflammatory drugs. Patients with two or more adjacent teeth requiring root canal therapy. Teeth that have: Vital pulp tissues. Association with swelling or fistulous tract. Acute or chronic peri-apical abscess. Greater than grade I mobility. Pocket depth greater than 5mm. No possible restorability. Previous endodontic treatment.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients having mandibular molars with necrotic pulp
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TruNatomy Files<br>Newly introduced endodontic file | Device: TruNatomy Files<br>* Newly introduced endodontic file with high flexibility.<br>|
| Experimental: Hyflex EDM<br>Endodontic file | Device: HyFlex EDM Files<br>* Endodontic files<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain | The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome. | Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesics taken by the patient after endodontic treatment | Counting Number of analgesics taken by the patient after endodontic treatment | up to 7 days post-operatively |