Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.

Detailed Description
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Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit. Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication. Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.

Official Title
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Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial

Conditions
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Non-Vital Tooth

Intervention / Treatment
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* Drug: Piroxicam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aging between 18-50 years old Patients with mandibular molar with non-vital pulp. Systemically- healthy patients (ASA I or II). Patients who agree to attend for recall appointments and provide a written consent. Exclusion Criteria: Pregnant or lactating female patients. Patients allergic to piroxicam. History of peptic ulceration. Periapical abscess, fistula. Non-restorable teeth. Moderate or severe marginal periodontitis i.e. pocket probe>3mm.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piroxicam drug<br>20 mg piroxicam | Drug: Piroxicam<br>* 20mg piroxicam<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit | 6 hours | 
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit | 12 hours | 
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit | 24 hours | 
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit | 48 hours | 
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit | 72 hours | 
| Postendodontic pain using a pain-measuring scale | Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic medication intake incidence | Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Piroxicam, Postendodontic pain, analgesic intake