Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Pulpitis - Irreversible
• Intervention / Treatment: Drug: Diclofenac Potassium 50mg Tab; Drug: Placebo

Detailed Description

This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with active pain (moderate-to-severe) in mandibular molars.
• Patients with prolonged response to cold testing and electric pulp tester.
• Patient with the ability to understand and use pain scales.
• Patient with vital coronal pulp tissue on access.
• Patient who accept to enroll to the study.

Exclusion Criteria:

• Patients' allergies or any other contraindication to diclofenac potassium or articaine.
• Pregnant and lactating females.
• Patients having pain medication in the last 6 hours.
• Patient has more than one symptomatic mandibular tooth in the same quadrant.
• Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
• Patients with active peptic ulcer and gastrointestinal disorders.
• Patients with history of bleeding problems or anticoagulant use within the last month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Diclofenac Potassium 50mg tab; Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.	Drug: Diclofenac Potassium 50mg Tab; A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.; Other Names: Cataflam 50mg
PLACEBO_COMPARATOR: Placebo; Placebo to be administered one hour before treatment.	Drug: Placebo; A placebo will be taken one hour before initiation of endodontic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of articaine buccal infiltration.	Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on injection	The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.	Intraoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amatallah H Al-Rawhani, Postgraduate, Faculty of Oral and Dental Medicine/ Cairo University.; Study Director: Dr. Suzan AW Amin, PhD, Faculty of Oral and Dental Medicine/ Cairo University.; Study Director: Shaima'a Gawdat, PhD, Faculty of Oral and Dental Medicine/ Cairo University.

Publications and helpful links

General Publications

• Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
• Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pulpitis, irreversible Pulpitis, Hot tooth; Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic; Local anesthesia, Articaine, Buccal infiltration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: CEBC-CU-2016-11-167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No