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

Cairo University70 enrolled

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Irreversible Pulpitis

Interventions

AceclofenacDRUG

Aceclofenac 100 mg tablet given one hour before starting the root canal treatment

PlaceboOTHER

Placebo tablet given one hour before starting the root canal treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients in good health (American Society of Anesthesiologists Class I or Class II). * Patients having symptomatic irreversible pulpitis in one of their mandibular molars * Age is 18 years or older. * Patients who can understand Heft- Parker Visual Analogue Scales. * Patients able to sign informed consent. Exclusion Criteria: * Patients allergic to aceclofenac or Mepivacaine. * Pregnant or nursing women. * Patients having active pain in more than one molar in the same quadrant. * Administration of analgesics within 12 h before the administration of the study drug.

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Anesthetic success

Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.

Time frame: intraoperative

Secondary Outcomes

Pain on injection of inial IANB

Pain on injection of inial IANB will be measured with Heft-Parker VAS

Time frame: intraoperative

Data from ClinicalTrials.gov

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