Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

N/ACompletedNCT05920811

Tanta University10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Maxillofacial Prosthesis User

Interventions

conventional obturatorOTHER

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

3 d printed obturatorOTHER

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

marwa Mohammed Amer

Tanta, ElGharbia, Egypt

Outcomes

Primary Outcomes

obturator functioning scale

The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"

Time frame: 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)

Time frame: 6 months

operator outcome

Questions focused on the treatment time, on the self-perception of the applied impression

Time frame: 6 months

Data from ClinicalTrials.gov

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