Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05920811

Collaborator

(none)

Enrollment

Location

Arms

14.5

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillofacial Prosthesis User	Other: conventional obturator Other: 3 d printed obturator	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

Jun 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	marwa Mohammed Amer	Tanta	ElGharbia	Egypt	31512

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: marwa M Amer, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Mohammed Amer, lecturer, Tanta University

ClinicalTrials.gov Identifier:

NCT05920811

Other Study ID Numbers:

prosth 6/23

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Marwa Mohammed Amer, lecturer, Tanta University

maxillary obturator, selective laser melting

Study Results

No Results Posted as of Jun 27, 2023