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Completed

NCT Number: NCT05920811

Patient Satisfaction for Digital Versus Conventional Maxillary Obturator

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.

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Key information

Conditions

Maxillofacial Prosthesis User

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

marwa Mohammed Amer

Tanta, ElGharbia, 31512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional obturator

Other

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

3 d printed obturator

Other

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

Primary outcomes

  1. obturator functioning scale

    Time frame: 6 months

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

  2. 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.

    Time frame: 6 months

    questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)

  3. operator outcome

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.