Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01593930
First received: May 4, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).


Condition Intervention
Pulpal Anesthesia
Other: Lidocaine(IANB)
Other: 1 Articaine(Infiltration)
Other: 2 Articaine(Infiltration)
Other: Lidocaine(IANB)+1Articaine(Infiltration)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Zahedan University of Medical Sciences:

Primary Outcome Measures:
  • Success rate [ Time Frame: Every 3 minutes after injection ] [ Designated as safety issue: No ]
    Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.


Secondary Outcome Measures:
  • Onset of anesthesia [ Time Frame: Every 3 minutes after injection ] [ Designated as safety issue: No ]
    Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. No response from the patient at the 80 reading of EPT in 2 consecutive tests will be discerned as "completely anesthetized" and the time will be recorded as "onset of anesthesia".

  • Duration of anesthesia [ Time Frame: Every 3 minutes after onset of anesthesia ] [ Designated as safety issue: No ]
    Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after onset of anesthesia to determine when the subject will response again at the 80 reading of EPT.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Articaine(Infiltration)
Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other: 1 Articaine(Infiltration)
Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other Name: Septanest
Experimental: 2 Articaine(Infiltration)
Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
Other: 2 Articaine(Infiltration)
Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
Other Name: Septanest
Experimental: Lidocaine(IANB)+1Articaine(Infiltration)
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other: Lidocaine(IANB)+1Articaine(Infiltration)
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
Other Name: Persocaine E + Septanest
Experimental: Lidocaine(IANB)
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
Other: Lidocaine(IANB)
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
Other Name: Persocaine E

Detailed Description:

According to inclusion & exclusion criteria, volunteers will be selected and divided into 4 groups randomly. The clinician who does the injections will not be aware of study purpose. Also the person who does the electric pulp test (EPT); the volunteer and the statistical analyzer will not be aware of group codes. Intervention in each group will be as follow: Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group 3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4- Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine. Before injection a control tooth (contralateral canine) will be tested to understand the accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth will be evaluated by EPT twice before injection. After injection each tooth will be evaluated by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked, up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in addition to the success rate the mean time for onset of anesthesia and its mean duration time will be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with at least 1 vital first mandibular molar without any restoration or decay

Exclusion Criteria:

  • Patients with systemic conditions which eliminate the use of epinephrine
  • Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
  • Pregnant women
  • Use of analgesics, opioids or any other drugs which influence the anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593930

Locations
Iran, Islamic Republic of
Zahedan university of medical sciences, Vice-chancellor for research
Zahedan, Iran, Islamic Republic of
Sponsors and Collaborators
Zahedan University of Medical Sciences
Investigators
Principal Investigator: Kaveh Oloomi, DDS, MS Assistant Professor
  More Information

No publications provided

Responsible Party: Kaveh Oloomi, DDS, MS, Assistant Professor, Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01593930     History of Changes
Other Study ID Numbers: Articaine pulpal anesthesia
Study First Received: May 4, 2012
Last Updated: January 28, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Zahedan University of Medical Sciences:
Pulp Anesthesia
Articaine
Lidocaine

Additional relevant MeSH terms:
Epinephrine
Lidocaine
Carticaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on April 16, 2014