Effect of Buffered Numbing Solution on Patients With Toothaches

Not Applicable

Completed

• Conditions: Irreversible Pulpitis (Toothache)
• Interventions: Drug: buffered lidocaine; Drug: nonbuffered lidocaine

• Registration Number: NCT01868776
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-04-20
• Results First Submitted QC: 2015-05-11
• Results First Posted: 2015-05-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
buffered lidocaine	buffered lidocaine	4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.
nonbuffered lidocaine	nonbuffered lidocaine	4% lidocaine with 1:100,000 epinephrine

Primary Outcome Measures

Name	Time	Method
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.	approximately 15 minutes after injection	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.

Trial Locations

Locations (1)

The Ohio State University College of Dentistry, Postle Hall; 🇺🇸 Columbus, Ohio, United States