Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diclofenac Potassium 50mg tab

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

Group Type EXPERIMENTAL

Diclofenac Potassium 50mg Tab.

Intervention Type DRUG

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

Placebo

Placebo to be administered one hour before treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Diclofenac Potassium 50mg Tab.

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No