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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 4, 2012

Last Updated Date

January 28, 2013

Start Date ^ICMJE

May 2012

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01593930 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Pulpal Anesthesia

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01593930

Other Study ID Numbers ^ICMJE

Articaine pulpal anesthesia

Has Data Monitoring Committee

Responsible Party

Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences

Study Sponsor ^ICMJE

Zahedan University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kaveh Oloomi, DDS, MS

Assistant Professor

Information Provided By

Zahedan University of Medical Sciences

Verification Date

January 2013

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

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