Effect of Sufentanil on the Rate of Anesthesia

Phase 2

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Drug: Lidocaine with Epinephrine + sufentanil; Drug: Lidocaine with Epinephrine+ Normal saline

• Registration Number: NCT01572116
• Lead Sponsor: Islamic Azad University, Tehran

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Study First Submitted: 2012-03-03
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-04
• Last Update Submitted: 2012-04-04
• Study First Posted: 2012-04-06
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine with Epinephrine + sufentanil	Lidocaine with Epinephrine + sufentanil	-
Lidocaine with Epinephrine+ Normal saline	Lidocaine with Epinephrine+ Normal saline	-

Primary Outcome Measures

Name	Time	Method
depth of anesthesia	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

Secondary Outcome Measures

Name	Time	Method
intensity of the pain	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)

Trial Locations

Locations (1)

Dental School of Azad University; 🇮🇷 Tehran, Iran, Islamic Republic of