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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedFirst Submitted
Initial submission to the registry
June 17, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedJune 27, 2023
June 1, 2023
1.1 years
June 17, 2023
June 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
conventional obturator
ACTIVE COMPARATORmaxillary obturator fabricated from cast metal framework, heat-cured acrylic resin
3 d printed obturator
EXPERIMENTAL3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin
Interventions
restoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin
restoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients with physical or mental disorders.
- patients still receiving radio or chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
marwa Mohammed Amer
Tanta, ElGharbia, 31512, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
marwa M Amer
Tanta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
June 17, 2023
First Posted
June 27, 2023
Study Start
April 1, 2022
Primary Completion
May 1, 2023
Study Completion
June 15, 2023
Last Updated
June 27, 2023
Record last verified: 2023-06