Effect of Sufentanil on the Rate of Anesthesia

April 4, 2012 updated by: Mandana Abedi Tari, Islamic Azad University, Tehran

Comparison the Effect of Lidocaine (With Epinephrine) With and Without Sufentanil on the Rate of Anesthesia of Intra-ligamentary Injection in Teeth With Irreversible Pulpitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Lidocaine with Epinephrine+ Normal saline
Drug: Lidocaine with Epinephrine+ Normal saline
PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
ACTIVE_COMPARATOR: Lidocaine with Epinephrine + sufentanil
Drug: Lidocaine with Epinephrine + sufentanil
PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)
Other Names:
  • Brand name:Sufenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depth of anesthesia
Time Frame: in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment
The measuring method of the pain is Electric pulp tester
in different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intensity of the pain
Time Frame: before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy
The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)
before the treatment,Immediately after treatment, from commencement of treatment until complete pulpotomy stage, from commencement of treatment until initial file determination ,from commencement of treatment until end of pulpectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Investigators

  • Principal Investigator: Mandana Abedi Tari, Dentist, Dental School of Azad University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

March 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRCT201110137790N1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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