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Effect of Lidocaine/Dexamethasone on the Success of IANB

Phase 2
Completed
Conditions
Local Anesthesia
Interventions
Drug: Placebo
Registration Number
NCT03531970
Lead Sponsor
Isfahan University of Medical Sciences
Brief Summary

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.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DexamethasoneDexamethasonelidocaine \& Dexamethasone
Non-dexamethasonePlacebolidocaine \& Placebo
Primary Outcome Measures
NameTimeMethod
success of IAN Block anesthesia for the Dexamethasone group15 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.

success of IAN Block anesthesia for the Non-dexamethasone group15 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 Outcome Measures
NameTimeMethod
initial painBaseline

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.

Trial Locations

Locations (1)

Isfahan University of Medical Sciences

🇮🇷

Isfahan, Iran, Islamic Republic of

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