Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits

Study Overview
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Brief Summary
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The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

Detailed Description
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Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

Official Title
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Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits

Conditions
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Irreversible Pulpitis, Pain

Intervention / Treatment
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* Drug: 4% articaine with 1:100,000 epinephrine
* Drug: 2% lidocaine with 1:100,000 epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: long-lasting moderate to severe pain during cold test absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs) vital coronal pulp on access opening Exclusion Criteria: Previous history of allergy to local anesthetics Subjects with systemic diseases Pregnancy and lactation Subjects taking any kind of medication that could change or influence the outcome of this research Subjects without painful symptoms Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Articaine<br>injection of 1.8 mL buccal infiltrations of 4% articaine with 1:100,000 epinephrine in one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. | Drug: 4% articaine with 1:100,000 epinephrine<br>* If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.<br>* Other names: articaine;Drug: 2% lidocaine with 1:100,000 epinephrine<br>* If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.<br>* Other names: Lidocaine;|
| Active Comparator: Lidocaine<br>1.8 mL 2% lidocaine with 1:100,000 epinephrine injected as inferior alveolar nerve block in the mandible side with one tooth with a clinical diagnosis of symptomatic irreversible pulpitis. | Drug: 4% articaine with 1:100,000 epinephrine<br>* If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.<br>* Other names: articaine;Drug: 2% lidocaine with 1:100,000 epinephrine<br>* If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.<br>* Other names: Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception 3 | Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection. | 10 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buccal cortical bone thickness | Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness. | one week after injection | 
| Root distance to the bone | Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone. | one week after injection | 
| Basal pain perception | Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection. | 10 minutes before injection | 
| Pain perception 2 | Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing). | 5 minutes before injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpitis, Hot tooth, Articaine, Lidocaine, Local anesthetics