Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Phase 2

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Placebo; Drug: Diclofenac Potassium 50mg Tab.

• Registration Number: NCT03341260
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-11-05
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-14
• Primary Completion: 2018-02
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to be administered one hour before treatment.
Diclofenac Potassium 50mg tab	Diclofenac Potassium 50mg Tab.	Diclofenac Potassium 50mg tablet to be administered one hour before treatment.

Primary Outcome Measures

Name	Time	Method
Postoperative endodontic pain	Up to 2 days after endodontic treatment	Pain after completion root canal treatment measured by Heft-parker visual analogue scale.

Secondary Outcome Measures

Name	Time	Method
Analgesic intake	Up to 2 days after endodontic treatment	The incidence of analgesic intake is recorded

Trial Locations

Locations (1)

Dentistry Faculty; 🇪🇬 Cairo, Egypt