Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

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

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.

Study Overview

• Status: Completed
• Conditions: Maxillofacial Prosthesis User
• Intervention / Treatment: Other: conventional obturator; Other: 3 d printed obturator

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbia
    • Tanta, ElGharbia, Egypt, 31512
      • marwa Mohammed Amer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obturator functioning scale	The Obturator Functioning Scale ( minimum value is "1"and 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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: marwa M Amer, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: June 17, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: maxillary obturator, selective laser melting
• Other Study ID Numbers: prosth 6/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes