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Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT03163420
Recruitment Status : Unknown
Verified October 2016 by Aya Ahmed Youssef, Cairo University.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Aya Ahmed Youssef, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Drug: Diclofenac potassium Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


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 Name: Catafast-Novartis International AG, Basel, Switzerland




Primary Outcome Measures :
  1. anesthetic success [ Time Frame: Intraoperative ]
    Pain during treatment is measured using Heft Parker VAS


Secondary Outcome Measures :
  1. Pain on injection of initial IANB [ Time Frame: Intraoperative ]
    measured using Heft Parker VAS



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03163420


Locations
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Egypt
Faculty of Oral and dental medicine, Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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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:
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Responsible Party: Aya Ahmed Youssef, Postgraduate student, Cairo University
ClinicalTrials.gov Identifier: NCT03163420     History of Changes
Other Study ID Numbers: CEBC-CU-2016-10-149
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aya Ahmed Youssef, Cairo University:
Anesthetic efficacy
Diclofenac
Irreversible pulpitis
Additional relevant MeSH terms:
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Diclofenac
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action