Effect of Sufentanil on the Rate of Anesthesia

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572116
• Other study ID #: IRCT201110137790N1
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2012
• Last updated: April 4, 2012
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• Lidocaine with Epinephrine+ Normal saline
PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
• Lidocaine with Epinephrine + sufentanil
PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 µg)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental School of Azad University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depth of anesthesia	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	No
Secondary	intensity of the pain	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	No