Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341260
• Other study ID #: CEBC-CU-2016-11-167
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 5, 2017
• Last updated: April 6, 2018
• Start date: December 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Diclofenac Potassium 50mg Tab.
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
• Placebo
A placebo will be taken one hour before initiation of endodontic treatment.

Locations

Country	Name	City	State
Egypt	Dentistry Faculty	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative endodontic pain	Pain after completion root canal treatment measured by Heft-parker visual analogue scale.	Up to 2 days after endodontic treatment
Secondary	Analgesic intake	The incidence of analgesic intake is recorded	Up to 2 days after endodontic treatment