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

NCT02747186 | Completed Results

• 1 other identifier: 16-0068b
• Study Type: interventional
• Target: 24
• 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 buffered drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published 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 Maxillary Molar Anesthesia

  Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.

  Every 30 minutes up to 120 minutes Total

• Mean Time to Pulpal Response After Maxillary Canine Anesthesia

  Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.

  Every 30 minute up to 120 minutes total

Study Arms (2)

Buffered 1% lidocaine

ACTIVE COMPARATOR

In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves.Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.

Drug: Lidocaine

Non-Buffered lidocaine

ACTIVE COMPARATOR

In week One each subject would receive the anesthetic, 5cc, to block the Posterior alveolar, Anterior alveolar, Palatal nerves. Maxillary molar and canine tested for pulpal anesthesia. At least a week later, injections for the maxillary field block would involve the alternate local anesthetic combination. Maxillary molar and canine tested for pulpal anesthesia.

Drug: Lidocaine

Interventions

Lidocaine DRUG

Intraoral maxillary field block

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:

• American Society of Anesthesiologists Risk Classification I Willingness to participate in two sessions

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)

University of North Carolina 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 Department 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: April 19, 2016
• First Posted: April 21, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)