Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

NCT01951820 | Completed Phase 4 Results

• 1 other identifier: HUM00075036
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.

Conditions

Anesthesia of Mucous Membrane

Outcome Measures

Primary Outcomes (1)

• Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale

  The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).

  2.5 minutes

Study Arms (2)

Benzocaine

ACTIVE COMPARATOR

Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.

Drug: Benzocaine; Drug: Articaine

Pliaglis

EXPERIMENTAL

Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.

Drug: Pliaglis; Drug: Articaine

Interventions

Pliaglis DRUG

Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.

Also known as: lidocaine and tetracaine

Pliaglis

Benzocaine DRUG

Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.

Also known as: Hurricaine

Benzocaine

Articaine DRUG

Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed

Also known as: Septocaine

Benzocaine; Pliaglis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars
• Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site
• Ability to use and understand a VAS score
• Ability to use and understand a VAS score
• No know allergies to topical anesthetics being used

You may not qualify if:

• Allergy or other contraindications to topical anesthetics
• Allergy to epinephrine or local anesthetics
• Broken/unhealthy mucosal tissues and pain on palpation at injection site
• Patients needing endodontic therapy on maxillary anterior teeth
• Inability to consent to participate in the study
• Patients who have used analgesics within 6 hours of appointment time
• Pregnant and nursing women

Sponsors & Collaborators

• University of Michigan: lead
• American Association of Endodontists: collaborator

Study Sites (1)

University of Michigan Dental School

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Lidocaine; Tetracaine; Benzocaine; Carticaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Carlos Gonzalez
• Organization: University of Michigan School of Dentistry

carlosgc@umich.edu

734-763-3391

Study Officials

• Brian l Royle, DDS

  University of Michigan department of Endodontics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic Resident

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 27, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 22, 2016
• Results First Posted: July 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)