Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

NCT02708433 | Completed Results

• 1 other identifier: 16-0068a
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures

Conditions

Anesthesia

Keywords

lidocaine, jaw

Outcome Measures

Primary Outcomes (2)

• Mean Time to Pulpal Response After Mandibular Molar Anesthesia

  Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a "yes" or "no."

  Every 30 minutes up to 120 minutes total

• Mean Time to Pulpal Response After Mandibular Canine Anesthesia

  Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants "yes" or "no."

  Every 30 minutes up to 120 minutes total

Study Arms (2)

Buffered 1% lidocaine

ACTIVE COMPARATOR

In week one each subject would receive either anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves. In week two the alternate anesthetic would be administered. Mandibular molar and canine tested for pulpal anesthesia

Drug: Lidocaine

Non-Buffered lidocaine

ACTIVE COMPARATOR

In week two each subject would receive the alternate anesthetic (Buffered 1% lidocaine with 1/100,000 Epinephrine) or (Non-Buffered 2% lidocaine with 1/100,000 Epinephrine) to block the inferior alveolar, lingual, buccal nerves. Mandibular molar and canine tested for pulpal anesthesia

Drug: Lidocaine

Interventions

Lidocaine DRUG

Lidocaine

Also known as: xylocaine

Buffered 1% lidocaine; Non-Buffered lidocaine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30 years, ASA I

You may not qualify if:

• Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Raymond P. White, Jr. DDS, PhD
• Organization: University of North Carolina at Chapel Hill

ray_white@unc.edu

919-537-3944

Study Officials

• Raymond P White, Jr., DDS, PhD

  UNC Dept Oral and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)