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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

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date July 19, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03174860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
Official Title  ICMJE Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Pulpitis - Irreversible
  • Anesthesia, Local
Intervention  ICMJE
  • 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
  • Drug: Placebo
    A placebo will be taken one hour before initiation of endodontic treatment.
Study Arms  ICMJE
  • Experimental: Diclofenac Potassium 50mg tab
    Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.
    Intervention: Drug: Diclofenac Potassium 50mg Tab
  • Placebo Comparator: Placebo
    Placebo to be administered one hour before treatment.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2017)
66
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03174860
Other Study ID Numbers  ICMJE CEBC-CU-2016-11-167
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amatallah Hussein Nasser Al-Rawhani, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Cairo University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP