NCT03163420

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

May 15, 2017

Last Update Submit

May 20, 2017

Conditions

Irreversible Pulpitis

Keywords

Anesthetic efficacyDiclofenacIrreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • anesthetic success

    Pain during treatment is measured using Heft Parker VAS

    Intraoperative

Secondary Outcomes (1)

  • Pain on injection of initial IANB

    Intraoperative

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Other: Placebo

Diclofenac potassium

EXPERIMENTAL

Diclofenac potassium 50 mg

Drug: Diclofenac potassium

Interventions

Diclofenac potassiumDRUG

Diclofenac potassium 50 mg granules for oral solution

Also known as: Catafast-Novartis International AG, Basel, Switzerland
Diclofenac potassium
PlaceboOTHER

Fructose

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and dental medicine, Cairo University

Cairo, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 21692235BACKGROUND

  • 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.

    PMID: 27656053BACKGROUND

  • 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.

    PMID: 27042580BACKGROUND

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Khaled M Ezzat, Professor

    Faculty of Oral and Dental medicine, Cairo University

    STUDY DIRECTOR

  • Suzan AW Amin, PhD

    Faculty of Oral and Dental medicine, Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 23, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)