Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

May 20, 2017 updated by: Aya Ahmed Youssef, Cairo University

Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.

Design: Randomized double-blind controlled trial.

Setting and conduct:

  • Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
  • Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
  • Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.
  • During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.
  • Main outcome measures: Anesthetic success during root canal treatment using HP VAS.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of oral and dental medicine, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
  2. Age range is between 18 and 50 years.
  3. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
  4. Patients who can understand Heft Parker Visual Analogue Scales VAS.
  5. Patients accepting to participate in the study and able to sign informed consent.

Exclusion Criteria:

  1. Pregnant female patient.
  2. Patients allergic to diclofenac potassium or mepivacaine.
  3. Patients having active pain in more than one mandibular molar.
  4. Patients who had taken analgesics in the 12 hours preceding the injection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo
Other: Placebo
Fructose
Experimental: Diclofenac potassium
Diclofenac potassium 50 mg
Drug: Diclofenac potassium
Diclofenac potassium 50 mg granules for oral solution
Other Names:
  • Catafast-Novartis International AG, Basel, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anesthetic success
Time Frame: Intraoperative
Pain during treatment is measured using Heft Parker VAS
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on injection of initial IANB
Time Frame: Intraoperative
measured using Heft Parker VAS
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Khaled M Ezzat, Professor, Faculty of oral and dental medicine, Cairo university
  • Study Chair: Suzan AW Amin, PhD, Faculty of oral and dental medicine, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 20, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 20, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2016-10-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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