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Trial record 53 of 452 for:    DICLOFENAC

Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain

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ClinicalTrials.gov Identifier: NCT03341260
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Amatallah Hussein Nasser Al-Rawhani, 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.

Condition or disease Intervention/treatment Phase
Pulpitis - Irreversible Drug: Diclofenac Potassium 50mg Tab. Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Diclofenac Potassium 50mg tab
Diclofenac Potassium 50mg tablet to be administered one hour before treatment.
Drug: Diclofenac Potassium 50mg Tab.
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.

Placebo Comparator: Placebo
Placebo to be administered one hour before treatment.
Drug: Placebo
A placebo will be taken one hour before initiation of endodontic treatment.




Primary Outcome Measures :
  1. Postoperative endodontic pain [ Time Frame: Up to 2 days after endodontic treatment ]
    Pain after completion root canal treatment measured by Heft-parker visual analogue scale.


Secondary Outcome Measures :
  1. Analgesic intake [ Time Frame: Up to 2 days after endodontic treatment ]
    The incidence of analgesic intake is recorded



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341260


Locations
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Egypt
Dentistry Faculty
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Amatallah H Al-Rawhani, Pos Faculty of Oral and Dental Medicine/ Cairo University.

Publications:
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Responsible Party: Amatallah Hussein Nasser Al-Rawhani, Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University., Cairo University
ClinicalTrials.gov Identifier: NCT03341260     History of Changes
Other Study ID Numbers: CEBC-CU-2016-11-167
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Amatallah Hussein Nasser Al-Rawhani, Cairo University:
Pulpitis, irreversible Pulpitis,
Diclofenac Potassium
Premedication, Preoperative Analgesic
Postoperative pain
Additional relevant MeSH terms:
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Diclofenac
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action