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Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

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ClinicalTrials.gov Identifier: NCT01951820
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Collaborator:
American Association of Endodontists
Information provided by (Responsible Party):
Brian Royle, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Anesthesia of Mucous Membrane Drug: Pliaglis Drug: Benzocaine Drug: Articaine Phase 4

Detailed Description:

This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.

In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.

The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Benzocaine
Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Drug: Benzocaine
Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Other Name: Hurricaine

Drug: Articaine
Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
Other Name: Septocaine

Experimental: Pliaglis
Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
Drug: Pliaglis
Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
Other Name: lidocaine and tetracaine

Drug: Articaine
Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
Other Name: Septocaine




Primary Outcome Measures :
  1. Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale [ Time Frame: 2.5 minutes ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951820


Locations
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United States, Michigan
University of Michigan Dental School
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
American Association of Endodontists
Investigators
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Principal Investigator: Brian l Royle, DDS University of Michigan department of Endodontics
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Responsible Party: Brian Royle, Endodontic Resident, University of Michigan
ClinicalTrials.gov Identifier: NCT01951820    
Other Study ID Numbers: HUM00075036
First Posted: September 27, 2013    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lidocaine
Tetracaine
Benzocaine
Carticaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action