Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits

Detailed Description
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Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension. Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment. In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo. Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).

Official Title
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Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial

Conditions
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Pulpitis

Intervention / Treatment
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* Drug: Celebrex premedication
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically free patients Patients able to understand Visual Analogue Scale and sign the informed conset Mandibular molar teeth with: Preoperative sharp pain Vital pulp tissue Normal peripaical radiographic appearance or slight widening of the lamina dura Exclusion Criteria: Patients allergic to NSAIDS Pregnant females Patients having significant systemic disorder Patients with psychological disturbances Patients with bruxism or clenching Teeth that have: Associated with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Periodontitis No possible restorability previous endodontic treatment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Celebrex premedication<br>Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain | Drug: Celebrex premedication<br>* celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.<br>* Other names: Celecoxib;|
| Placebo Comparator: Placebo tablets<br>placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits | Drug: Placebo<br>* placebo is given as a tablet before initiation of endodontic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity (intra-operative pain) | pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale) | 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alleviation of pain severity | severity of pain is measured by Visual Analogue Scale | 24 hours | 
| number of analgesic tablets taken by the patient after endodontic treatment | counting the number of analgesic tablets taken by the patient after the treatment | 24 hours |