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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-01-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pulpal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1 Articaine(Infiltration)

Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Group Type EXPERIMENTAL

1 Articaine(Infiltration)

Intervention Type OTHER

Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

2 Articaine(Infiltration)

Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine

Group Type EXPERIMENTAL

2 Articaine(Infiltration)

Intervention Type OTHER

Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine

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

Group Type EXPERIMENTAL

Lidocaine(IANB)+1Articaine(Infiltration)

Intervention Type OTHER

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Lidocaine(IANB)

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine

Group Type EXPERIMENTAL

Lidocaine(IANB)

Intervention Type OTHER

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine

Interventions

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Lidocaine(IANB)

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine

Intervention Type OTHER

1 Articaine(Infiltration)

Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Intervention Type OTHER

2 Articaine(Infiltration)

Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Persocaine E Septanest Septanest Persocaine E + Septanest

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes