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Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 22, 2013
First Posted Date  ICMJE September 27, 2013
Results First Submitted Date  ICMJE April 9, 2016
Results First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Anesthesia of Mucous Membrane
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • Active Comparator: Benzocaine
    Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
    Interventions:
    • Drug: Benzocaine
    • Drug: Articaine
  • Experimental: Pliaglis
    Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.
    Interventions:
    • Drug: Pliaglis
    • Drug: Articaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2013)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951820
Other Study ID Numbers  ICMJE HUM00075036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Royle, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE American Association of Endodontists
Investigators  ICMJE
Principal Investigator: Brian l Royle, DDS University of Michigan department of Endodontics
PRS Account University of Michigan
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP