Patient Satisfaction With Conventional Maxillary Obturator Versus Fully Digital Fabricated With 3D Printing: a Randomized Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- obturator functioning scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
conventional obturator
maxillary obturator fabricated from cast metal framework, heat-cured acrylic resin
Intervention: conventional obturator (Other)
3 d printed obturator
3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin
Intervention: 3 d printed obturator (Other)
Outcomes
Primary Outcomes
obturator functioning scale
Time Frame: 6 months
The Obturator Functioning Scale ( minimum value is "1"and 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.
Time Frame: 6 months
questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)
operator outcome
Time Frame: 6 months
Questions focused on the treatment time, on the self-perception of the applied impression
Secondary Outcomes
No secondary outcomes reported
Investigators
Marwa Mohammed Amer
lecturer
Tanta University