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Completed

NCT Number: NCT01572116

Effect of Sufentanil on the Rate of Anesthesia

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.

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Key information

Conditions

Irreversible Pulpitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dental School of Azad University

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine with Epinephrine+ Normal saline

Drug

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

Lidocaine with Epinephrine + sufentanil

Drug

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

Other names: Brand name:Sufenta

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2012
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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