Demand for complete denture treatment is expected to rise over several decades. However, to date, no questionnaire on complete dentures, as evaluated by edentulous patients, has been shown to be reliable and valid. This study sought to assess the reliability and validity of Patient’s Denture Assessment (PDA), which provides a multidimensional evaluation of dentures among edentulous patients.

Patients, who had new complete dentures fabricated at the University Hospital of Dentistry, Tokyo Medical and Dental University through 2009 to 2010, were enrolled. The reliability of the PDA was determined by examining internal consistency and test-retest reliability. Internal consistency for all of the question items and the six subscales was measured using Cronbach’s α and average inter-item correlation coefficients among 93 participants. For 33 of these participants, test-retest reliability was determined at a 2 month-interval using the interclass correlation coefficients (ICCs) and 95% confidence interval for the summary scores and the six subscale scores. The PDA was validated in 93 participants by examining the difference in the summary score and the six subscale scores of the PDA before and after replacement with new dentures by the paired t-test. Ability to detect change was also tested in 93 patients using effect size.

The Cronbach’s α for the PDA ranged from 0.56 to 0.93. The average inter-item correlation coefficients ranged from 0.28 to 0.83. ICCs for the PDA ranged from 0.37 to 0.83. The paired t-test showed a significant difference between the summary score and the six subscale scores before and after replacement with new dentures (p < 0.05) and the effect size was 0.97.

The PDA demonstrated good reliability by assessing internal consistency and test-retest reliability. In addition, the PDA demonstrated good validity by assessing discriminant validity. Thus, the PDA could help dentists obtain a detailed understanding of the patients’ perceptions in using their dentures.