Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.

Official Title
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Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexamethasone sodium phosphate
* Drug: Piroxicam Injectable Solution
* Drug: Mepivacaine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patient (ASA I or II). Mandibular Posterior teeth with: Preoperative sharp pain. Absence of widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). Exclusion Criteria: Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids). Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Hemostatic disorders or anti-coagulant therapy during the last month. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment. Retreatment cases.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: dexamethasone<br>Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt) | Drug: Dexamethasone sodium phosphate<br>* prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.<br>|
| Experimental: piroxicam<br>Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt) | Drug: Piroxicam Injectable Solution<br>* prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam<br>|
| Active Comparator: Mepivacaine HCL<br>Pretreatment Intraligamentary injection of 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml (Mepecaine - L, Alexandria Co.-Egypt) | Drug: Mepivacaine HCL<br>* prophylactic intraligamentary supplemental injection 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessed with the Numerical Rating Pain Scale | Intensity of pain after endodontic treatment is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain ) | up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of analgesics taken by the patient | Number of analgesic tablets taken by the patient after endodontic treatment. | Until 48 hours after endodontic treatment. |