NCT03146481

Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.

Detailed description

* The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis. * Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit. * Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered. * During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	Aceclofenac	Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
OTHER	Placebo	Placebo tablet given one hour before starting the root canal treatment

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-05-10
• Last updated: 2017-11-07

Locations

1 site across 1 country: Egypt