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Effect of Sufentanil on the Rate of Anesthesia

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lidocaine with Epinephrine+ Normal saline
Lidocaine with Epinephrine + sufentanil
Sponsored by
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irreversible Pulpitis focused on measuring sufentanil, irreversible pulpitis, intra ligament injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dental School of Azad University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Lidocaine with Epinephrine+ Normal saline

Lidocaine with Epinephrine + sufentanil

Arm Description

Outcomes

Primary Outcome Measures

depth of anesthesia
The measuring method of the pain is Electric pulp tester

Secondary Outcome Measures

intensity of the pain
The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)

Full Information

First Posted
March 3, 2012
Last Updated
April 4, 2012
Sponsor
Islamic Azad University, Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01572116
Brief Title
Effect of Sufentanil on the Rate of Anesthesia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
sufentanil, irreversible pulpitis, intra ligament injection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine with Epinephrine+ Normal saline
Arm Type
Placebo Comparator
Arm Title
Lidocaine with Epinephrine + sufentanil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine with Epinephrine+ Normal saline
Intervention Description
PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
Intervention Type
Drug
Intervention Name(s)
Lidocaine with Epinephrine + sufentanil
Other Intervention Name(s)
Brand name:Sufenta
Intervention Description
PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)
Primary Outcome Measure Information:
Title
depth of anesthesia
Description
The measuring method of the pain is Electric pulp tester
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
Secondary Outcome Measure Information:
Title
intensity of the pain
Description
The measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandana Abedi Tari, Dentist
Organizational Affiliation
Dental School of Azad University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental School of Azad University
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Sufentanil on the Rate of Anesthesia

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