Effect of Lidocaine/Dexamethasone on the Success of IANB

Local Anesthesia Clinical Trial

— IANB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531970
• Other study ID #: 396731
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: May 2018
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• 2% lidocaine with 1:80,000 epinephrine
Anesthetic solution
• Dexamethasone
Corticostroide
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of IAN Block anesthesia for the Dexamethasone group	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)
Primary	success of IAN Block anesthesia for the Non-dexamethasone group	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	initial pain	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