Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Lower Premolars

Study Overview
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Brief Summary
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The aim of this study is to clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.

Detailed Description
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To clinically compare post-operative pain levels after ultrasonic activation of Ceraseal bioceramic sealer versus non-activated bioceramic sealer for patients with symptomatic irreversible pulpitis related to mandibular premolar teeth.Ultrasonic activation of Ceraseal bioceramic sealer for 20 seconds using non cutting ultrasonic tip.

Official Title
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The Effect of Ultrasonic Activation of Bioceramic Sealer on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Other: ultrasonic activation of bioceramic sealer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above 18 years old and to 50. Male or female. Patients seeking root canal treatment. Mandibular posterior teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura. Systematically healthy patient (ASA I, II). Patient who can understand modified VAS and sign informed consent 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. External root resorption. Internal root resorption. Vertical root fracture. Periapical lesion. Association with swelling. Acute peri-apical abscess or acute exacerbation of a chronic abscess. Pregnancy. Use of ibuprofen in the last 12 hour. Bleeding disorder. Long term corticosteroid use. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: ultrasonic activation of bioceramic sealer<br>ultrasonic activation of bioceramic sealer for 20 seconds | Other: ultrasonic activation of bioceramic sealer<br>* activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction<br>|
| Active Comparator: bioceramic sealer<br>bioceramic sealer | Other: ultrasonic activation of bioceramic sealer<br>* activation of bioceramic sealer using ultrasonic tip for 20 seconds in buccolingual and mesiodistal direction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | intensity of pain on modified Visual analogue scale | 6 hours | 
| postoperative pain | intensity of pain on modified Visual analogue scale | 12 hours | 
| postoperative pain | intensity of pain on modified Visual analogue scale | 24 hours | 
| postoperative pain | intensity of pain on modified Visual analogue scale | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of analgesic tablets taken by patient after endodontic treatment | number of analgesics taken by patient in 1st 48 hours | up to 48 hours postoperatively | 
| Sealer Extrusion laterally and periapically | presence or absence of sealer extrusion | Immediately after obturation. |