A Proof-of-concept Study Using Quantitative Sensory Threshold Analysis to Compare Two Intraoral Topical Anesthetics.

Area of Science:

• Anesthesiology
• Pharmacology

Background:

• Topical anesthetics are crucial for dental procedures.
• Benzocaine and tetracaine are commonly used agents.
• CTY-5339A is an investigational combination topical anesthetic spray.

Purpose of the Study:

• To compare the local anesthetic efficacy of CTY-5339A (14% benzocaine/2% tetracaine) with 14% benzocaine alone.
• To evaluate anesthetic effects using quantitative sensory testing on the maxillary gingiva.

Main Methods:

• Double-blind, randomized, crossover study with 50 subjects.
• Used pin prick test pain intensity (PPT PI) and heat pain threshold (HPT) to assess anesthesia.
• Administered one spray of CTY-5339A or 14% benzocaine, with crossover after 5-14 days.
• Monitored PPT PI and HPT at various time points up to 60 minutes.
• Assessed methemoglobin and oxygen saturation levels.

Main Results:

• CTY-5339A showed significantly greater AUCs for PPT PI and HPT differences compared to 14% benzocaine (P < 0.0001).
• Multiple time points favored CTY-5339A for both PPT PI and HPT.
• No significant changes in methemoglobin or oxygen saturation were observed for either treatment.

Conclusions:

• CTY-5339A provides more profound and sustained local anesthesia than 14% benzocaine.
• The combination spray is safe, with no observed adverse effects on methemoglobin or oxygen saturation.
• CTY-5339A represents a potentially more effective topical anesthetic option.