Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.

Detailed Description
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40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Official Title
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Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution
* Drug: 2% lidocaine with 1:100,000 epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - In order to participate, subjects must: Be between the ages of 18 and 80 years old Have the ability and willingness to independently consent to treatment and study participation Have an uncomplicated medical history (ASA I and II) Not be pregnant Have no allergies local anesthetics/sulfites (confirmed or self-reported) Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours) Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study Exclusion Criteria - No subjects will have: A negative response to cold in the proposed treatment tooth A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buffered 2% lidocaine with 1:100,000 epinephrine<br>Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) | Drug: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution<br>* Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic<br>Drug: 2% lidocaine with 1:100,000 epinephrine<br>* Septodont's standard formulation of 2% lidocaine with epinephrine<br>|
| Active Comparator: Unbuffered 2% lidocaine with 1:100,000 epinephrine<br>Standard local anesthetic | Drug: 2% lidocaine with 1:100,000 epinephrine<br>* Septodont's standard formulation of 2% lidocaine with epinephrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profoundness of pulpal anesthesia | Number of Participants who demonstrate profound pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation) | Up to 20 minutes post-drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of pulpal anesthesia | Duration of time required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (maximum stimulation) | Up to 20 minutes post-drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, buffered, local anesthetic, irreversible pulpitis