Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

Study Overview
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Brief Summary
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to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

Detailed Description
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The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Official Title
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Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Procedure: intraligamentary injection piroxicam
* Procedure: Intraligamentary mepevacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Medically free patients Patient's age between 25-50 years. Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis. Positive patient's acceptance for participation in the study. Sex include both male and female. Patients who can understand Numerical Rating Scale (NRS) Patients able to sign informed consent. Exclusion Criteria: • Pregnancy or lactation in female patients Medically compromised patients. Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral. Patient with fracture or mobile or mutilated teeth.

Ages Eligible for Study
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Minimum Age: 25 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: intraligamentary injection of piroxicam<br>intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone | Procedure: intraligamentary injection piroxicam<br>* intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone<br>|
| Active Comparator: Intraligamentary mepevacaine<br>mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures. | Procedure: Intraligamentary mepevacaine<br>* mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results. | Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents no pain , 1- 3 readings represent mild pain , 4- 6 readings represent moderate pain , 7- 10 readings represent severe pain No or mild pain will be considered as success while moderate or severe pain will be regarded as failure. | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irreversible pulpitis, Post endodontic pain, Symptomatic pulpitis pain, Single visit RCT pain, Root canal treatment flare up, Single dose piroxicam, Intraligamentary piroxicam, Intraligamentary mepecaine