Clinical Trial: Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Cairo University

Current Primary Outcome: anesthetic success [ Time Frame: Intraoperative ]

Pain during treatment is measured using Heft Parker VAS


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain on injection of initial IANB [ Time Frame: Intraoperative ]

measured using Heft Parker VAS


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: May 15, 2017
Date Started: July 2016
Date Completion: July 2017
Last Updated: May 20, 2017
Last Verified: October 2016