Anesthesia of Mucous Membrane
Conditions
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.
Interventions
DRUGPliaglis
Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
DRUGBenzocaine
Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
DRUGArticaine
Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
Sponsors
American Association of Endodontists
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 30 |
| Total | 64 |
Baseline characteristics
| Characteristic | Benzocaine | Pliaglis | Total |
|---|---|---|---|
| Age, Customized >18 Years | 34 participants | 30 participants | 64 participants |
| Region of Enrollment United States | 34 participants | 30 participants | 64 participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 30 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 |
Outcome results
Primary
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).
Time frame: 2.5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Benzocaine | Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale | 38.5 mm |
| Pliaglis | Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale | 26.9 mm |