Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars

Study Overview
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Brief Summary
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The purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique fails, a commonly used supplemental (SUP) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics. Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe. The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits. This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.

Detailed Description
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The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by IANB administration of 4% articaine with 1:100,000 epinephrine (NDA 022466), or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine. The proposed randomized controlled trial (RCT) aims to answer the following questions: What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration? Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB? Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine? This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size, giving a total sample size of approximately 200 patients.

Official Title
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Articaine Versus Lidocaine Supplemental Infiltration Efficacy in Irreversible Pulpitis Mandibular Molars After Failed Inferior Alveolar Nerve Block

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Drug: IANB Articaine
* Drug: SUP Articaine
* Drug: SUP Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients irreversible pulpitis in mandibular molar Exclusion Criteria: below 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: IANB Articaine<br>IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic. | Drug: IANB Articaine<br>* IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.<br>* Other names: Articadent (Dentsply Pharmaceutical);|
| Active Comparator: SUP Articaine<br>SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB. | Drug: IANB Articaine<br>* IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.<br>* Other names: Articadent (Dentsply Pharmaceutical);Drug: SUP Articaine<br>* After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).<br>* Other names: Articadent (Dentsply Pharmaceutical);|
| Active Comparator: SUP Lidocaine<br>SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB. | Drug: IANB Articaine<br>* IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.<br>* Other names: Articadent (Dentsply Pharmaceutical);Drug: SUP Lidocaine<br>* After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).<br>* Other names: Generic lidocaine (Henry Schein Inc);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic Success Rate of Supplemental Infiltration Injection | Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia | 5 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic Success Rate of an IANB With Articaine | Success rate of an IANB with articaine using a conventional IANB technique | 15 min after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Articaine, Lidocaine, Anesthesia, Local, Endodontics, Molar, Dental Pulp Diseases