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NCT Number: NCT01868776

Effect of Buffered Numbing Solution on Patients With Toothaches

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.

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Key information

Conditions

Irreversible Pulpitis (Toothache) Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Dentistry, Postle Hall

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buffered Lidocaine

Drug

nonbuffered lidocaine

Drug

Primary outcomes

  1. Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)

    Time frame: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2013
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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