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Effect of Sufentanil on the Rate of Anesthesia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01572116
Enrollment
60
Registered
2012-04-06
Start date
2010-01-31
Completion date
2011-10-31
Last updated
2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

sufentanil, irreversible pulpitis, intra ligament injection

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.

Interventions

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

DRUGLidocaine with Epinephrine + sufentanil

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

Sponsors

Islamic Azad University, Sanandaj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
depth of anesthesiain different times such as :before the treatment,and during the treatment in these times: 1,5,9,13,17 minutes after starting the treatmentThe measuring method of the pain is Electric pulp tester

Secondary

MeasureTime frameDescription
intensity of the painbefore 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 pulpectomyThe measuring method of the pain is Visual mentreatAnalogue Scale (VAS 0-170 mm)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026