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Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

Primary Purpose

Pulpitis - Irreversible, Anesthesia, Local

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Diclofenac Potassium 50mg Tab
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulpitis - Irreversible focused on measuring Pulpitis, irreversible Pulpitis, Hot tooth, Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic, Local anesthesia, Articaine, Buccal infiltration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac Potassium 50mg tab

Placebo

Arm Description

Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.

Placebo to be administered one hour before treatment.

Outcomes

Primary Outcome Measures

Success of articaine buccal infiltration.
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

Pain on injection
The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.

Full Information

First Posted
May 9, 2017
Last Updated
July 18, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03174860
Brief Title
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
Official Title
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible, Anesthesia, Local
Keywords
Pulpitis, irreversible Pulpitis, Hot tooth, Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic, Local anesthesia, Articaine, Buccal infiltration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Potassium 50mg tab
Arm Type
Experimental
Arm Description
Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to be administered one hour before treatment.
Intervention Type
Drug
Intervention Name(s)
Diclofenac Potassium 50mg Tab
Other Intervention Name(s)
Cataflam 50mg
Intervention Description
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo will be taken one hour before initiation of endodontic treatment.
Primary Outcome Measure Information:
Title
Success of articaine buccal infiltration.
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Pain on injection
Description
The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amatallah H Al-Rawhani, Postgraduate
Organizational Affiliation
Faculty of Oral and Dental Medicine/ Cairo University.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Suzan AW Amin, PhD
Organizational Affiliation
Faculty of Oral and Dental Medicine/ Cairo University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaima'a Gawdat, PhD
Organizational Affiliation
Faculty of Oral and Dental Medicine/ Cairo University.
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24702239
Citation
Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
Results Reference
background
PubMed Identifier
21692235
Citation
Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
Results Reference
background

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Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

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