Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia of Mucous Membrane
• Intervention / Treatment: Drug: Benzocaine; Drug: Articaine; Drug: Pliaglis

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: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Articaine; Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed; Other Names: Septocaine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale	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).	2.5 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Association of Endodontists
• Investigators: Principal Investigator: Brian l Royle, DDS, University of Michigan department of Endodontics

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: June 12, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Benzocaine; Tetracaine; Carticaine
• Other Study ID Numbers: HUM00075036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No