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Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Patient Satisfaction With Conventional Maxillary Obturator Versus Fully Digital Fabricated With 3D Printing: a Randomized Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05920811
Enrollment
10
Registered
2023-06-27
Start date
2022-04-01
Completion date
2023-06-15
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofacial Prosthesis User

Keywords

maxillary obturator, selective laser melting

Brief summary

Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning Scale and The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

Detailed description

The use of digital technologies in the fabrication of maxillofacial prostheses has been described. Additive manufacturing offers a more convenient and more efficient process with reduced material waste compared with traditional subtractive technique. Although Prosthetic rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted metal framework using, heat-cured acrylic resin can restore oral function and facial esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple sources of errors can accumulate during the laboratory steps, resulting in a misfit of the framework. In this study All patients received a conventional obturator for 6 months, after a washout period of one week, they use the digital one. The Obturator Functioning Scale and The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

Interventions

OTHER3 d printed obturator

restoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin

restoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* patients with hemimaxillectomy defect (Aramany class 1) * almost edentulous mandible with healthy remaining teeth, * mouth opening is not less than 25 mm, intact soft palate * participants were not exposed to radiotherapy or chemotherapy in the previous year

Exclusion criteria

* patients with physical or mental disorders. * patients still receiving radio or chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
obturator functioning scale6 monthsThe Obturator Functioning Scale ( minimum value is 1and maximum value is 5
patient outcome the treatment time, on the self-perception of the applied impression protocol in terms of general convenience, anxiety, taste, nausea sensation and possible pain sensation.6 monthsquestions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)
operator outcome6 monthsQuestions focused on the treatment time, on the self-perception of the applied impression

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026