Trial Outcomes & Findings for Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis (NCT NCT01951820)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

2.5 minutes

Results posted on

2016-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Pliaglis 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	Benzocaine 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
Overall Study STARTED	30	34
Overall Study COMPLETED	30	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benzocaine n=34 Participants 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 n=30 Participants 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 n=64 Participants Total of all reporting groups
Age, Customized >18 Years	34 participants n=93 Participants	30 participants n=4 Participants	64 participants n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Region of Enrollment United States	34 participants n=93 Participants	30 participants n=4 Participants	64 participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Benzocaine n=34 Participants 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 n=30 Participants 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
Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale	38.5 mm Interval 0.0 to 170.0	26.9 mm Interval 0.0 to 170.0

Adverse Events

Benzocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pliaglis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos Gonzalez

University of Michigan School of Dentistry

Phone: 734-763-3391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place