Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00846690

Enrollment

Registered

2009-02-19

Start date

2009-01-31

Completion date

2009-05-31

Last updated

2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain, Postoperative Pain

Keywords

topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia

Brief summary

The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an active control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).

Interventions

DRUGbenzocaine

20% benzocaine., topical placement onto site, minimal amount, for 1 minute

DRUGTAC alternate gel

use 1 pump, place topically onto site, leave for 1-3 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

1. Volunteers 18 years or older 2. Ability to consent to participate in the research 3. Ability to communicate a VAS score 4. Generally healthy, ASA I and ASA II 5. No known drug allergies 6. Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence

Exclusion criteria

1. Allergy or other contraindications to the topical anesthetics 2. Inability to consent to participation in the study 3. Use of analgesics prior to the procedure 4. Vulnerable populations

Design outcomes

Primary

Measure	Time frame
visual analogue scale score	pre-op, insertion, every minute post-op for 10 minutes

Secondary

Measure	Time frame
blood pressure	three times pre-op, insertion, ten times post-op
oxygen saturation	three times pre-op, insertion, ten times post-op
heart rate	three times pre-op, insertion, ten times post-op

Countries

United States

Contacts

Primary ContactFemme L Ambrosio, DDS

femme.l.ambrosio@uth.tmc.edu858 603-6345

Backup ContactArthur H Jeske, DDS, PhD

arthur.h.jeske@uth.tmc.edu713 500 4506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026