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NCT Number: NCT03341260

Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

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Key information

Conditions

Pulpitis - Irreversible Dental Pulp Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulpitis Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dentistry Faculty

Cairo, Egypt

About this study

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac Potassium 50mg Tab.

Drug

A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.

Placebo

Drug

A placebo will be taken one hour before initiation of endodontic treatment.

Primary outcomes

  1. Postoperative endodontic pain

    Time frame: Up to 2 days after endodontic treatment

    Pain after completion root canal treatment measured by Heft-parker visual analogue scale.

Secondary outcomes

  1. Analgesic intake

    Time frame: Up to 2 days after endodontic treatment

    The incidence of analgesic intake is recorded

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Preoperative, Single-dose Diclofenac Potassium on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2017
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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