Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files

Study Overview
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Brief Summary
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The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.

Official Title
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Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files in Non-vital Lower Molars: A Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: Rotary Neoniti GPS file
* Other: Manual stainless steel K-files


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients (ASA I or II) Lower permanent molar teeth with: Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions. Exclusion Criteria: Medically compromised patients having significant systemic disorders. (ASA III or IV). History of intolerance to NSAIDS. Patients with two or more adjacent teeth requiring endodontic treatment. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions. Teeth with: Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotary Neoniti GPS<br>Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France). | Other: Rotary Neoniti GPS file<br>* Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.<br>|
| Active Comparator: Stainless steel K-files<br>Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland). | Other: Manual stainless steel K-files<br>* Glide path preparation will be done by hand instrumentation using K-files #10 and 15.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed using the Visual Analogue Scale | Intensity of pain after root canal treatment will be recorded by the patient where; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 6 hours post treatment. | 
| Postoperative pain assessed using the Visual Analogue Scale | Intensity of pain after root canal treatment will be recorded by the patient where; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 12 hours post-treatment. | 
| Postoperative pain assessed using the Visual Analogue Scale | Intensity of pain after root canal treatment will be recorded by the patient where; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 24 hours post-treatment. | 
| Postoperative pain assessed using the Visual Analogue Scale | Intensity of pain after root canal treatment will be recorded by the patient where; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 48 hours post-treatment. | 
| Postoperative pain assessed using the Visual Analogue Scale | Intensity of pain after root canal treatment will be recorded by the patient where; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 72 hours post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesic tablets taken by the patient | Number of analgesic tablets taken by the patient after root canal treatment. | Up to 72 hours post treatment. |