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Completed

NCT Number: NCT03174860

Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry

Cairo, Egypt

About this study

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.

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.

Other names: Cataflam 50mg

Placebo

Drug

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

Primary outcomes

  1. Success of articaine buccal infiltration.

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Pain on injection

    Time frame: Intraoperative

    The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
Jul 19, 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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