Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

NCT ID: NCT05920811

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-06-15

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.

Conditions

Maxillofacial Prosthesis User

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional obturator

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

Group Type: ACTIVE_COMPARATOR

conventional obturator

Intervention Type: OTHER

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

3 d printed obturator

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

Group Type: EXPERIMENTAL

3 d printed obturator

Intervention Type: OTHER

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

Interventions

conventional obturator

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

Intervention Type: OTHER

3 d printed obturator

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohammed Amer

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marwa M Amer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

marwa Mohammed Amer

Tanta, ElGharbia, Egypt

Countries

Egypt

Other Identifiers

prosth 6/23

Identifier Type: -

Identifier Source: org_study_id