Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

Study Overview
=================
Brief Summary
-----------------
Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

Detailed Description
-----------------
The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university. The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit. After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

Official Title
-----------------
Effect Of Using XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Single Visit Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Device: XP Endo Finisher
* Device: ultrasonic activated irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically- free of any systemic disease Male or female Patients with age range 25-45 Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis. Teeth with mature root Restorable teeth Teeth without calcified root canals Teeth without root caries Teeth without internal or external root resorption Teeth with no sign of crack formation Teeth without anatomic abnormalities Exclusion Criteria: Pregnant females. If analgesics have been administrated during the past two weeks preoperatively. Patients having bruxism or clenching. Multi rooted or multi canaled teeth. Patients with swelling or acute peri-apical abscess. Previously endodontically treated teeth periodontally affected teeth .

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XP Endo Finisher file<br>XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol | Device: XP Endo Finisher<br>* a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature<br>|
| Active Comparator: ultrasonic activated irrigation<br>ultrasonic activated irrigation as a final step in irrigation protocol | Device: ultrasonic activated irrigation<br>* by Satelec,Acteon, France<br>* Other names: Irrisafe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | measured by NRS (Numerical rate scale) | up to 1 week after the visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of taken analgesic tablets | counted by the patient and recorded in a given chart | within a week after the visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
XP Endo Finisher, ultrasonic activated irrigation, postoperative pain