Effect of Sufentanil on the Rate of Anesthesia

NCT ID: NCT01572116

Last Updated: 2012-04-06

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

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-10-31

Brief Summary

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

The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.

Detailed Description

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

Conditions

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

Irreversible Pulpitis

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

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Lidocaine with Epinephrine+ Normal saline

Group Type PLACEBO_COMPARATOR

Lidocaine with Epinephrine+ Normal saline

Intervention Type DRUG

PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline

Lidocaine with Epinephrine + sufentanil

Group Type ACTIVE_COMPARATOR

Lidocaine with Epinephrine + sufentanil

Intervention Type DRUG

PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)

Interventions

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

Lidocaine with Epinephrine+ Normal saline

PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline

Intervention Type DRUG

Lidocaine with Epinephrine + sufentanil

PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)

Intervention Type DRUG

Other Intervention Names

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

Brand name:Sufenta

Eligibility Criteria

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

Inclusion Criteria

* patients in the age group of 18-65 years old
* healthy (ASA I, II)
* patients with first or second mandibular molars who need endodontic treatment
* vital tooth without a history of past endodontic treatment
* patients with clinical evidence of irreversible Pulpits with moderate to severe pain
* patients who signed consent form
* patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.

Exclusion Criteria

* pregnant or nursing
* necrotic tooth
* patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
* Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
* patient with infectious diseases
* patient with moderate to sever periodontal disease
* those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Islamic Azad University, Sanandaj

OTHER

Sponsor Role lead

Responsible Party

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

Mandana Abedi Tari

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Mandana Abedi Tari, Dentist

Role: PRINCIPAL_INVESTIGATOR

Dental School of Azad University

Locations

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

Dental School of Azad University

Tehran, Tehran Province, 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.

IRCT201110137790N1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Buffered Local Anesthetic
NCT05757648 COMPLETED PHASE4