Background <p>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.</p> Methods <p>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.</p> Results <p>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 <i>p</i>-values 0.010* and 0.014* respectively. On the other hand, there were no significant differences in chewing limitation and social disability, with <i>p</i>-values of 0.572 and 0.087 respectively.</p> Conclusion <p>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.</p> Trial registration <p>This research was registered on <a href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</a> in 17-06-2023 with registration number NCT0592081.</p>

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

  • Maha M. AboShady,
  • Marwa M. Amer

摘要

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.