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Completed

NCT Number: NCT01951820

Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis

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.

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Key information

Conditions

Anesthesia of Mucous Membrane

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Dental School

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pliaglis

Drug

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

Benzocaine

Drug

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

Other names: Hurricaine

Articaine

Drug

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

Other names: Septocaine

Primary outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Association of Endodontists

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 27, 2013
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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