Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

NCT03341260 | Completed Phase 2

• 1 other identifier: CEBC-CU-2016-11-167
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis - Irreversible

Keywords

Pulpitis, irreversible Pulpitis,; Diclofenac Potassium; Premedication, Preoperative Analgesic; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative endodontic pain

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

  Up to 2 days after endodontic treatment

Secondary Outcomes (1)

• Analgesic intake

  Up to 2 days after endodontic treatment

Study Arms (2)

Diclofenac Potassium 50mg tab

EXPERIMENTAL

Diclofenac Potassium 50mg tablet to be administered one hour before treatment.

Drug: Diclofenac Potassium 50mg Tab.

Placebo

PLACEBO COMPARATOR

Placebo to be administered one hour before treatment.

Drug: Placebo

Interventions

Diclofenac Potassium 50mg Tab. DRUG

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

Diclofenac Potassium 50mg tab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dentistry Faculty

Cairo, Egypt

Location

Related Publications (2)

• Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.

  PMID: 27080115 BACKGROUND

• Metri M, Hegde S, Bhandi S. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial. J Conserv Dent. 2016 Jan-Feb;19(1):7-10. doi: 10.4103/0972-0707.173183.

  PMID: 26957785 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amatallah H Al-Rawhani, Pos

  Faculty of Oral and Dental Medicine/ Cairo University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.

Model Details: The patients will be randomly divided into 2 groups: Experimental group: 50 mg Diclofenac Potassium to be administered one hour before treatment. Control group: Placebo to be administered one hour before treatment.

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 14, 2017
• Study Start: December 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)