Patient satisfaction with conventional versus fully digital obturators fabricated with 3D printing: a randomized crossover trial

BACKGROUND: Evidence concerning the performance of entirely 3D printed digital obturators is insufficient. This prospective randomized, single-blind crossover study aimed to evaluate patient satisfaction with conventional obturators and 3D printed obturators. METHODS: Ten patients aged between 45 and 65 years with unilateral hemi-maxillectomy due to oncological surgeries were enrolled in a crossover design. Initial treatment involved a conventional obturator with a heat-cured acrylic base and a cast metal framework GI. Following a two-week washout, patients received a fully digitally designed and fabricated obturator incorporating 3D printed materials GII. Satisfaction was assessed using the validated Obturator Functioning Scale (OFS), and statistical analysis was conducted using the Mann-Whitney U test. RESULTS: The median of OFS scores of the two groups were statistically significant differences between the two studied groups in terms of functional and aesthetic limitations, with p-values 0.010* and 0.014* respectively. On the other hand, there were no significant differences in chewing limitation and social disability, with p-values of 0.572 and 0.087 respectively. CONCLUSION: Within the limitations of this study, a full digital workflow for producing maxillary obturator prostheses can increase patient satisfaction with respect to functional, aesthetic, and phonetic outcomes. TRIAL REGISTRATION: This research was registered on www. CLINICALTRIALS: gov in 17-06-2023 with registration number NCT0592081.