Effect of Buffered Numbing Solution on Patients With Toothaches

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.

Official Title
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Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Conditions
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Irreversible Pulpitis (Toothache)

Intervention / Treatment
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* Drug: buffered lidocaine
* Drug: nonbuffered lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain ages 18 -65 years of age in good health (ASA I or II) able to grant informed consent. Exclusion Criteria: allergy to lidocaine (numbing solution significant medical problem (ASA III or IV) have taken CNS depressants or analgesic medications within the last 24 hours pregnancy or lactating non-English speaking inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: buffered lidocaine<br>4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. | Drug: buffered lidocaine<br> <br> |
| Active Comparator: nonbuffered lidocaine<br>4% lidocaine with 1:100,000 epinephrine | Drug: nonbuffered lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) |  | pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection | 
| Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis. | 100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm. | approximately 15 minutes after injection |