Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maxillofacial Prosthesis User

Intervention / Treatment
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* Other: conventional obturator
* Other: 3 d printed obturator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional obturator<br>maxillary obturator fabricated from cast metal framework, heat-cured acrylic resin | Other: conventional obturator<br>* restoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin<br>|
| Experimental: 3 d printed obturator<br>3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin | Other: 3 d printed obturator<br>* restoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obturator functioning scale | The Obturator Functioning Scale ( minimum value is 1and maximum value is 5 | 6 months | 
| 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. | questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS) | 6 months | 
| operator outcome | Questions focused on the treatment time, on the self-perception of the applied impression | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary obturator, selective laser melting