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Completed

NCT Number: NCT03531970

Effect of Lidocaine/Dexamethasone on the Success of IANB

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.

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Key information

Conditions

Local Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Isfahan University of Medical Sciences

Isfahan, 8476890162, Iran

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% lidocaine with 1:80,000 epinephrine

Drug

Anesthetic solution

Other names: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)

Dexamethasone

Drug

Corticostroide

Other names: Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)

Placebo

Drug

Placebo

Other names: sterile distilled water (Samen Pharmaceutical Co, Iran)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: IANB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 22, 2018
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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