Equivalence testing with dental clinical trials

Area of Science:

• Dental Research
• Clinical Trials
• Biostatistics

Background:

• Traditional clinical trials often infer treatment equivalence from a lack of superiority.
• Equivalence testing methods, well-established in pharmaceuticals for bioequivalence, are underutilized in dental research.
• Existing dental literature rarely documents the application of direct equivalence testing.

Purpose of the Study:

• To introduce and discuss the application of equivalence testing in dental clinical trials.
• To contrast equivalence testing with traditional superiority testing.
• To explore the suitability of parallel and crossover designs for dental equivalence trials.

Main Methods:

• Contrasting equivalence and superiority testing methodologies.
• Comparing parallel and crossover designs within the context of equivalence testing.
• Illustrating equivalence trial methodology with a dental implant overdenture example.

Main Results:

• Equivalence testing offers a direct approach to demonstrating treatment comparability.
• Crossover designs are significantly more sample-efficient for equivalence trials than parallel designs.
• For 90% power, a crossover trial requires 24 subjects, while a parallel design needs over 150.

Conclusions:

• Equivalence testing, especially using crossover designs, is an efficient and appropriate methodology for dental clinical trials.
• The adoption of equivalence testing can enhance the rigor and efficiency of dental research.
• Further application of these statistical methods in dental research is recommended.