Combination of Buffered Anesthetic to Treat Mandibular Molars

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. 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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60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.

Official Title
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Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Lidocaine w/ epi
* Drug: Articaine w/ epi
* Drug: Mepivacaine plain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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<br>Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution) | Drug: Sodium bicarbonate<br>* Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic<br>* Other names: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio;Drug: Lidocaine w/ epi<br>* Septodont's standard formulation of 2% lidocaine with epinephrine<br>* Other names: 2% lidocaine with 1:100,000 epinephrine;Drug: Articaine w/ epi<br>* Septodont's standard formulation of 4% articaine with epinephrine<br>* Other names: 4% articaine with 1:100,000 epinephrine;Drug: Mepivacaine plain<br>* Septodont's standard formulation of 3% mepivacaine<br>* Other names: 3% Mepivacaine;|
| Active Comparator: Unbuffered<br>Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics | Drug: Lidocaine w/ epi<br>* Septodont's standard formulation of 2% lidocaine with epinephrine<br>* Other names: 2% lidocaine with 1:100,000 epinephrine;Drug: Articaine w/ epi<br>* Septodont's standard formulation of 4% articaine with epinephrine<br>* Other names: 4% articaine with 1:100,000 epinephrine;Drug: Mepivacaine plain<br>* Septodont's standard formulation of 3% mepivacaine<br>* Other names: 3% Mepivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) Scores as Measures of Profoundness of Pulpal Anesthesia | Patient will report their comfort during treatment based on a VAS graphic. Visual analog scale (VAS) is based on a scale of 1-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment meaning there was inadequate anesthesia. | Up to 20 minutes post-drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Pulpal Anesthesia | An electronic pulp tester will be used to assess anesthesia after anesthetic is administered | 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, articaine, mepivacaine, buffered local anesthetic, irreversible pulpitis