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Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

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ClinicalTrials.gov Identifier: NCT03174860
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : July 19, 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 Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.

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

Detailed Description:
This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.

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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:

Diclofenac Potassium (50 mg, Cataflam) 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 Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Diclofenac Potassium 50mg tab
Diclofenac Potassium 50mg (Cataflam) 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.
Other Name: Cataflam 50mg

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. Success of articaine buccal infiltration. [ Time Frame: Intraoperative ]
    Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.


Secondary Outcome Measures :
  1. Pain on injection [ Time Frame: Intraoperative ]
    The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.



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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): NCT03174860


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Amatallah H Al-Rawhani, Postgraduate Faculty of Oral and Dental Medicine/ Cairo University.
Study Director: Dr. Suzan AW Amin, PhD Faculty of Oral and Dental Medicine/ Cairo University.
Study Director: Shaima'a Gawdat, PhD 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: NCT03174860     History of Changes
Other Study ID Numbers: CEBC-CU-2016-11-167
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 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
Keywords provided by Amatallah Hussein Nasser Al-Rawhani, Cairo University:
Pulpitis, irreversible Pulpitis, Hot tooth
Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic
Local anesthesia, Articaine, Buccal infiltration
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Diclofenac
Carticaine
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants