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

January 28, 2013 updated by: Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Zahedan, Iran, Islamic Republic of
        • Zahedan university of medical sciences, Vice-chancellor for research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Persocaine E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: Every 3 minutes after injection
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.
Every 3 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of anesthesia
Time Frame: Every 3 minutes after injection
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".
Every 3 minutes after injection
Duration of anesthesia
Time Frame: Every 3 minutes after onset of anesthesia
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.
Every 3 minutes after onset of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahedan University of Medical Sciences

Investigators

  • Principal Investigator: Kaveh Oloomi, DDS, MS, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Articaine pulpal anesthesia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulpal Anesthesia

Clinical Trials on 1 Articaine(Infiltration)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe