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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

May 4, 2012
January 28, 2013
May 2012
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01593930 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
Not Provided

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulpal Anesthesia
  • Other: Lidocaine(IANB)
    Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
    Other Name: Persocaine E
  • Other: 1 Articaine(Infiltration)
    Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
    Other Name: Septanest
  • Other: 2 Articaine(Infiltration)
    Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
    Other Name: Septanest
  • 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: 1 Articaine(Infiltration)
    Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
    Intervention: Other: 1 Articaine(Infiltration)
  • Experimental: 2 Articaine(Infiltration)
    Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
    Intervention: Other: 2 Articaine(Infiltration)
  • 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
    Intervention: Other: Lidocaine(IANB)+1Articaine(Infiltration)
  • Experimental: Lidocaine(IANB)
    Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
    Intervention: Other: Lidocaine(IANB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01593930
Articaine pulpal anesthesia
No
Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
Zahedan University of Medical Sciences
Not Provided
Principal Investigator: Kaveh Oloomi, DDS, MS Assistant Professor
Zahedan University of Medical Sciences
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP