Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Tanta University

Status: Completed

Conditions: Maxillofacial Prosthesis User

Treatments: Other: 3 d printed obturator; Other: conventional obturator

Study type: Interventional

Funder types: Other

Identifiers

NCT05920811

prosth 6/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

conventional obturator

Active Comparator group

Description:

maxillary obturator fabricated from cast metal framework, heat-cured acrylic resin

Treatment:

Other: conventional obturator

3 d printed obturator

Experimental group

Description:

3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin

Treatment:

Other: 3 d printed obturator