Accuracy of Maxillary Obturator Bulb in Maxillectomy Defects (NCT06403930) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of Maxillary Obturator Bulb in Maxillectomy Defects
Egypt19 participantsStarted 2024-05-15
Plain-language summary
Treatment of tumors in the paranasal region often requires maxillectomy procedures. While surgical reconstruction is preferred, prosthetic reconstruction using obturators becomes necessary when surgery is not feasible. Obturators separate oral and nasal cavities, restoring functions like chewing, speech, and facial aesthetics, while alleviating psychological distress. The emergence of rapid prototyping (RP) technologies since 1995 has revolutionized prosthetic construction. RP techniques like stereolithography and 3D printing enable layer-by-layer production of accurate 3D models from computer designs. Combined with imaging like CT and MRI, RP allows creation of highly precise extraoral facial prostheses. For intraoral defects, integrating 3D CAD and RP can enhance prosthetic outcomes compared to conventional gypsum models, although obtaining accurate impressions remains challenging due to factors like defect size, undercuts, and mucosal issues.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* The study enrolled participants of all genders who had defects or abnormalities involving both hard and soft palate regions.
* Participants were included if their surgical site was fully healed and they had partial tooth loss or missing teeth in the maxilla defect area.
* Only cooperative patients capable of following instructions were selected.
Exclusion Criteria
* Individuals with temporomandibular disorders.
* uncontrolled diabetes.
* bleeding disorders.
* ongoing anticoagulant therapy.
* Patients with flabby tissues.
* sharp mandibular residual ridges.
* heavy smoking habits.
* neuromuscular disorders.
* severe psychiatric conditions were also not eligible for the study.
* The study did not include children, with only adult participants considered.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.