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Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Diclofenac potassium
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irreversible Pulpitis focused on measuring Anesthetic efficacy, Diclofenac, Irreversible pulpitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Oral and dental medicine, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Diclofenac potassium

Arm Description

placebo

Diclofenac potassium 50 mg

Outcomes

Primary Outcome Measures

anesthetic success
Pain during treatment is measured using Heft Parker VAS

Secondary Outcome Measures

Pain on injection of initial IANB
measured using Heft Parker VAS

Full Information

First Posted
May 15, 2017
Last Updated
May 20, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03163420
Brief Title
Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
Anesthetic efficacy, Diclofenac, Irreversible pulpitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Diclofenac potassium
Arm Type
Experimental
Arm Description
Diclofenac potassium 50 mg
Intervention Type
Drug
Intervention Name(s)
Diclofenac potassium
Other Intervention Name(s)
Catafast-Novartis International AG, Basel, Switzerland
Intervention Description
Diclofenac potassium 50 mg granules for oral solution
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Fructose
Primary Outcome Measure Information:
Title
anesthetic success
Description
Pain during treatment is measured using Heft Parker VAS
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Pain on injection of initial IANB
Description
measured using Heft Parker VAS
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in good health as determined by a medical history and oral questioning. (ASA I or II) Age range is between 18 and 50 years. Patients having symptomatic irreversible pulpitis in one of their mandibular molars. Patients who can understand Heft Parker Visual Analogue Scales VAS. Patients accepting to participate in the study and able to sign informed consent. Exclusion Criteria: Pregnant female patient. Patients allergic to diclofenac potassium or mepivacaine. Patients having active pain in more than one mandibular molar. Patients who had taken analgesics in the 12 hours preceding the injection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled M Ezzat, Professor
Organizational Affiliation
Faculty of Oral and Dental medicine, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Suzan AW Amin, PhD
Organizational Affiliation
Faculty of Oral and Dental medicine, Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Oral and dental medicine, Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
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PubMed Identifier
27656053
Citation
Shetkar P, Jadhav GR, Mittal P, Surapaneni S, Kalra D, Sakri M, Basavaprabhu A. Comparative evaluation of effect of preoperative alprazolam and diclofenac potassium on the success of inferior alveolar, Vazirani-Akinosi, and Gow-Gates techniques for teeth with irreversible pulpitis: Randomized controlled trial. J Conserv Dent. 2016 Sep-Oct;19(5):390-5. doi: 10.4103/0972-0707.190013.
Results Reference
background
PubMed Identifier
27042580
Citation
Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
Results Reference
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Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis

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