Comparing Articaine brands: A randomized non-inferiority controlled trial

Area of Science:

• Dental Anesthesiology
• Clinical Pharmacology

Background:

• Drug substitution decisions in dentistry require robust clinical evidence.
• Randomized controlled trials provide essential data for adopting new drugs.
• Evaluating new anesthetics against established references is crucial for clinical practice.

Purpose of the Study:

• To determine if Arteek-SP is noninferior to Septanest for pain absence during mandibular third molar extraction.
• To compare the clinical performance of Arteek-SP and Septanest using inferior alveolar nerve blocks.
• To assess secondary outcomes including hemodynamic parameters and postoperative discomfort.

Main Methods:

• 179 healthy volunteers undergoing mandibular third molar extraction were randomized into four groups.
• The study compared Arteek-SP (4% Articaine HCl with 1:10000 epinephrine) against Septanest.
• Noninferiority was defined as a <10% difference in total pain absence, with 90% power and 5% significance level.

Main Results:

• Arteek-SP was administered to 90 participants and Septanest to 89.
• Arteek-SP showed less than a 10% difference in total tooth pain absence (P < 0.05) and gum pain (P < 0.1) compared to Septanest.
• These results established the noninferiority of Arteek-SP.

Conclusions:

• Arteek-SP exhibits noninferior clinical performance compared to Septanest.
• The findings support the interchangeability of Arteek-SP and Septanest.
• Both anesthetics can be considered equivalent for use in dental procedures like third molar extraction.