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Effect of Lidocaine/Dexamethasone on the Success of IANB

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03531970
Acronym
IANB
Enrollment
100
Registered
2018-05-22
Start date
2016-08-01
Completion date
2017-12-01
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

inferior alveolar nerve block, irreversible pulpitis, local anesthesia, dexamethasone

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

Interventions

DRUGDexamethasone

Corticostroide

DRUGPlacebo

Placebo

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
initial painBaselinerating 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026