Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Anesthesia of Mucous Membrane

Treatments: Drug: Benzocaine; Drug: Articaine; Drug: Pliaglis

Study type: Interventional

Funder types: Other

Identifiers

NCT01951820

HUM00075036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Benzocaine

Active Comparator group

Description:

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

Treatment:

Drug: Articaine

Drug: Benzocaine

Pliaglis

Experimental group

Description:

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

Treatment:

Drug: Pliaglis

Drug: Articaine