Comparison Between M-Pro and ProTaper Next

Study Overview
=================
Brief Summary
-----------------
Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic Irreversible pulpitis molars.

Detailed Description
-----------------
Lower molars with symptomatic Irreversible pulpitis molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the treatment, patients will instructed to take placebo if they feel pain and will be asked to provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo, after recording the amount of pain, the patient will be instructed to take an alternative line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of Ibuprofen intake will be recorded.

Official Title
-----------------
Comparison of Postoperative Pain After Root Canal Instrumentation Using M-Pro and ProTaper Next in Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Conditions
-----------------
Symptomatic Irreversible Pulpitis

Intervention / Treatment
-----------------
* Procedure: M-pro files in rotating motion
* Procedure: ProTaper Next files in rotating motion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- Males or Females. 2- Mandibular molar teeth with: Pre-operative sharp pain. Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). Normal periapical radiographic appearance or slight widening in lamina dura using periapical index (PAI) score 1 as normal periapical structures or 2 as small changes in bone structures. Exclusion Criteria: 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: Necrotic 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: 18 Years
Maximum Age: 45 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
Interventional Model Description: Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A & B and randomly distributed. The table is kept with the assistant supervisor.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-pro files<br>Instrumentation using M-pro files in rotating motion | Procedure: M-pro files in rotating motion<br>* An endodontic file that has controlled memory properties<br>|
| Active Comparator: ProTaper Next files<br>Instrumentation using ProTaper Next files in rotating motion | Procedure: ProTaper Next files in rotating motion<br>* An endodontic file that has an off center mass of rotation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessed with numerical rating scale | 0 (none) to 10 (severe) Numerical Pain Rating Scale up to 72 hours post-operatively | Up to 72 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of placebo intake assessed by questioning | Amount of placebo intake up to 72 hours post-operatively | Up to 72 hours post-operatively | 
| Amount of analgesic intake assessed by counting | Number of analgesic tablets up to 72 hours post-operatively | Up to 72 hours post-operatively |