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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Anesthesia of Mucous Membrane
Interventions Drug: Pliaglis
Drug: Benzocaine
Drug: Articaine
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Benzocaine Pliaglis
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Overall Study
Started 34 30
Completed 34 30
Not Completed 0 0
Arm/Group Title Benzocaine Pliaglis Total
Hide Arm/Group Description

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

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

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 34 30 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>18 Years Number Analyzed 34 participants 30 participants 64 participants
34 30 64
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 30 participants 64 participants
Female
17
  50.0%
15
  50.0%
32
  50.0%
Male
17
  50.0%
15
  50.0%
32
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 30 participants 64 participants
34 30 64
1.Primary Outcome
Title Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale
Hide Description 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).
Time Frame 2.5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Benzocaine Pliaglis
Hide Arm/Group Description:

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

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

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

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

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

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

Overall Number of Participants Analyzed 34 30
Mean (Full Range)
Unit of Measure: mm
38.5
(0 to 170)
26.9
(0 to 170)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benzocaine Pliaglis
Hide Arm/Group Description

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

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

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

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

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

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

All-Cause Mortality
Benzocaine Pliaglis
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Benzocaine Pliaglis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Benzocaine Pliaglis
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carlos Gonzalez
Organization: University of Michigan School of Dentistry
Phone: 734-763-3391
EMail: carlosgc@umich.edu
Layout table for additonal information
Responsible Party: Brian Royle, University of Michigan
ClinicalTrials.gov Identifier: NCT01951820    
Other Study ID Numbers: HUM00075036
First Submitted: August 22, 2013
First Posted: September 27, 2013
Results First Submitted: April 9, 2016
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016