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 Overview
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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).

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

Intervention / Treatment
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* Other: Lidocaine(IANB)
* Other: 1 Articaine(Infiltration)
* Other: 2 Articaine(Infiltration)
* Other: Lidocaine(IANB)+1Articaine(Infiltration)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Articaine(Infiltration)<br>Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine | Other: 1 Articaine(Infiltration)<br>* Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine<br>* Other names: Septanest;|
| Experimental: 2 Articaine(Infiltration)<br>Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine | Other: 2 Articaine(Infiltration)<br>* Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine<br>* Other names: Septanest;|
| Experimental: Lidocaine(IANB)+1Articaine(Infiltration)<br>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)<br>* Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine<br>* Other names: Persocaine E + Septanest;|
| Experimental: Lidocaine(IANB)<br>Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine | Other: Lidocaine(IANB)<br>* Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine<br>* Other names: Persocaine E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulp Anesthesia, Articaine, Lidocaine