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Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Primary Purpose

Pulpitis - Irreversible

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Diclofenac Potassium 50mg Tab.

Placebo

About this trial

This is an interventional prevention trial for Pulpitis - Irreversible focused on measuring Pulpitis, irreversible Pulpitis,, Diclofenac Potassium, Premedication, Preoperative Analgesic, Postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dentistry Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac Potassium 50mg tab

Placebo

Arm Description

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

Placebo to be administered one hour before treatment.

Outcomes

Primary Outcome Measures

Postoperative endodontic pain

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

Secondary Outcome Measures

Analgesic intake

The incidence of analgesic intake is recorded

Full Information

NCT ID

NCT03341260

First Posted

November 5, 2017

Last Updated

April 6, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03341260

Brief Title

Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

December 2016 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulpitis - Irreversible

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diclofenac Potassium 50mg tab

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to be administered one hour before treatment.

Intervention Type

Drug

Intervention Name(s)

Diclofenac Potassium 50mg Tab.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative endodontic pain

Description

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

Time Frame

Up to 2 days after endodontic treatment

Secondary Outcome Measure Information:

Title

Analgesic intake

Description

The incidence of analgesic intake is recorded

Time Frame

Up to 2 days after endodontic treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amatallah H Al-Rawhani, Pos

Organizational Affiliation

Faculty of Oral and Dental Medicine/ Cairo University.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dentistry Faculty

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27080115

Citation

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.

Results Reference

background

PubMed Identifier

26957785

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.

Results Reference

background

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Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

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