Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Not Applicable

Completed

• Conditions: Maxillofacial Prosthesis User
• Interventions: Other: conventional obturator; Other: 3 d printed obturator

• Registration Number: NCT05920811
• Lead Sponsor: Tanta University

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 Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-05-01
• Status Verified: 2023-06
• Study Completion: 2023-06-15
• Study First Submitted: 2023-06-17
• Study First Submitted QC: 2023-06-17
• Last Update Submitted: 2023-06-17
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional obturator	conventional obturator	maxillary obturator fabricated from cast metal framework, heat-cured acrylic resin
3 d printed obturator	3 d printed obturator	3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin

Primary Outcome Measures

Name	Time	Method
obturator functioning scale	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.	6 months	questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)
operator outcome	6 months	Questions focused on the treatment time, on the self-perception of the applied impression

Trial Locations

Locations (1)

marwa Mohammed Amer; 🇪🇬 Tanta, ElGharbia, Egypt