Comparison Between Reciproc and Protaper Next

Study Overview
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Brief Summary
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Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.

Detailed Description
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Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.

Official Title
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Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial

Conditions
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Dental Pulp Necrosis

Intervention / Treatment
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* Procedure: Reciproc files in reciprocating motion
* Procedure: ProTaper Next files in continuous rotary motion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis Exclusion Criteria: Patients on medication for chronic pain Patients with pre-operative pain. Patients having significant systemic disorders. Patients with two or more adjacent teeth requiring root canal therapy teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reciproc file<br>Reciproc files in reciprocating motion | Procedure: Reciproc files in reciprocating motion<br>* An endodontic file that works through a reciprocating motion<br>|
| Active Comparator: ProTaper Next file<br>ProTaper Next files in continuous rotary motion | Procedure: ProTaper Next files in continuous rotary motion<br>* An endodontic file that works through a continuous rotary motion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessed with the Numerical Rating Pain Scale | 1 to 10 Numerical Rating Pain Scale up to 48 hours post-instrumentation | Up to 48 hours post-instrumentation | 
| Post-obturation pain assessed with the Numerical Rating Pain Scale | 1 to 10 Numerical Rating Pain Scale up to 24 hours following obturation | up to 24 hours following obturation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to complete instrumentation | time required to complete instrumentation | From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours |