Effect of Lidocaine/Dexamethasone on the Success of IANB

NCT ID: NCT03531970

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Local Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexamethasone

lidocaine \& Dexamethasone

Group Type EXPERIMENTAL

2% lidocaine with 1:80,000 epinephrine

Intervention Type DRUG

Anesthetic solution

Dexamethasone

Intervention Type DRUG

Corticostroide

Non-dexamethasone

lidocaine \& Placebo

Group Type PLACEBO_COMPARATOR

2% lidocaine with 1:80,000 epinephrine

Intervention Type DRUG

Anesthetic solution

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

2% lidocaine with 1:80,000 epinephrine

Anesthetic solution

Intervention Type DRUG

Dexamethasone

Corticostroide

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran) Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran) sterile distilled water (Samen Pharmaceutical Co, Iran)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Masoud Saatchi, DDS MSc

Professor of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Masoud Saatchi

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Isfahan University of Medical Sciences

Isfahan, , Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

396731

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.