Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

NCT03174860 | Completed Phase 2

• 1 other identifier: CEBC-CU-2016-11-167
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible; Anesthesia, Local

Keywords

Pulpitis, irreversible Pulpitis, Hot tooth; Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic; Local anesthesia, Articaine, Buccal infiltration

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative

Secondary Outcomes (1)

• Pain on injection

  Intraoperative

Study Arms (2)

Diclofenac Potassium 50mg tab

EXPERIMENTAL

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

Drug: Diclofenac Potassium 50mg Tab

Placebo

PLACEBO COMPARATOR

Placebo to be administered one hour before treatment.

Drug: Placebo

Interventions

Diclofenac Potassium 50mg Tab DRUG

A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.

Also known as: Cataflam 50mg

Diclofenac Potassium 50mg tab

Placebo DRUG

A placebo will be taken one hour before initiation of endodontic treatment.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24702239 BACKGROUND

• 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: 21692235 BACKGROUND

MeSH Terms

Conditions

Pulpitis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amatallah H Al-Rawhani, Postgraduate

  Faculty of Oral and Dental Medicine/ Cairo University.

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY DIRECTOR

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 in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 5, 2017
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)