NCT03163420

Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Detailed description

Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis. Design: Randomized double-blind controlled trial. Setting and conduct: * Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University. * Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit. * Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated. * During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered. * Main outcome measures: Anesthetic success during root canal treatment using HP VAS.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	Diclofenac potassium	Diclofenac potassium 50 mg granules for oral solution
OTHER	Placebo	Fructose

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-05-23
• Last updated: 2017-05-23

Locations

1 site across 1 country: Egypt