Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01951820
• Collaborator: American Association of Endodontists (Other)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Aug 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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 Names: Hurricaine ; Drug: Articaine; Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed; Other Names: 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 Names: lidocaine and tetracaine ; Drug: Articaine; Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed; Other Names: Septocaine

Outcome Measures

Primary Outcome Measures

1. Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Dental School	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• American Association of Endodontists

Investigators

• Principal Investigator: Brian l Royle, DDS, University of Michigan department of Endodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian Royle, Endodontic Resident, University of Michigan
• ClinicalTrials.gov Identifier: NCT01951820
• Other Study ID Numbers: HUM00075036
• First Posted: Sep 27, 2013
• Last Update Posted: Jul 22, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lidocaine; Tetracaine; Carticaine; Benzocaine

Study Results

Participant Flow

Arm/Group Title	Benzocaine	Pliaglis
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

Baseline Characteristics

Arm/Group Title	Benzocaine	Pliaglis	Total
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 Participants	34	30	64
Age, Customized (participants) [Number]
>18 Years	34 100%	30 100%	64 100%
Sex: Female, Male (Count of Participants)
Female	17 50%	15 50%	32 50%
Male	17 50%	15 50%	32 50%
Region of Enrollment (participants) [Number]
United States	34 100%	30 100%	64 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Benzocaine	Pliaglis
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
Measure Participants	34	30
Mean (Full Range) [mm]	38.5	26.9

Adverse Events

Time Frame	1 year
Arm/Group Title	Benzocaine		Pliaglis
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Benzocaine		Pliaglis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Benzocaine		Pliaglis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.