Effect of Lidocaine/Dexamethasone on the Success of IANB (IANB)

May 18, 2018 updated by: Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences

Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis

The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

  • younger than 18 years old
  • history of significant medical conditions
  • allergies to local anesthetics or sulfites
  • pregnancy
  • taking any medications that might influence anesthetic assessment
  • active sites of pathosis in area of injection
  • inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
lidocaine & Dexamethasone
Drug: 2% lidocaine with 1:80,000 epinephrine
Anesthetic solution
Other Names:
  • lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)
Drug: Dexamethasone
Corticostroide
Other Names:
  • Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)
Placebo Comparator: Non-dexamethasone
lidocaine & Placebo
Drug: Placebo
Placebo
Other Names:
  • sterile distilled water (Samen Pharmaceutical Co, Iran)
Drug: 2% lidocaine with 1:80,000 epinephrine
Anesthetic solution
Other Names:
  • lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of IAN Block anesthesia for the Dexamethasone group
Time Frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
15 minutes after the local anesthetic injection (at time of access cavity preparation)
success of IAN Block anesthesia for the Non-dexamethasone group
Time Frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
15 minutes after the local anesthetic injection (at time of access cavity preparation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initial pain
Time Frame: Baseline
rating the pain on Heft-Parker visual analog scale. This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Masoud Saatchi, Isfahan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 396731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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