Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

NCT ID: NCT01951820

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-06-30

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.

Conditions

Anesthesia of Mucous Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Benzocaine

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

Group Type: ACTIVE_COMPARATOR

Benzocaine

Intervention Type: DRUG

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

Articaine

Intervention Type: DRUG

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

Pliaglis

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

Group Type: EXPERIMENTAL

Pliaglis

Intervention Type: DRUG

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

Articaine

Intervention Type: DRUG

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

Interventions

Pliaglis

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

Intervention Type: DRUG

Benzocaine

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

Intervention Type: DRUG

Articaine

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

Intervention Type: DRUG

Other Intervention Names

lidocaine and tetracaine; Hurricaine; Septocaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Association of Endodontists

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Brian Royle

Endodontic Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian l Royle, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan department of Endodontics

Locations

University of Michigan Dental School

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00075036

Identifier Type: -

Identifier Source: org_study_id