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Can a prosthetic device restore quality of life after facial defects?

NCT ID NCT06515743

Symptom relief Sponsor: Menoufia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study looks at how a dental prosthetic called an obturator affects quality of life in people who have had part of their upper jaw removed due to COVID-19-associated mucormycosis or oral cancer. Researchers will compare patient-reported quality of life at different stages of rehabilitation, from after surgery to after receiving the final obturator. The goal is to see if this approach helps improve daily functioning and well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Obturator prosthetic rehabilitation
What this could lead to
If successful, this could help tailor rehabilitation approaches to improve quality of life for patients with maxillary defects from mucormycosis or oral cancer.
What could go wrong
This is a small retrospective study, so results may not apply broadly. Outcomes rely on patient-reported measures, which can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

42 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a retrospective observational cohort study. Patients were identified from existing clinical records of individuals who underwent maxillectomy for oral neoplasm or COVID-19-associated mucormycosis between 2021 and 2024. A total of 65 records were screened; 23 were excluded (15 oral neoplasm, 8 CAM); 42 patients met the eligibility criteria and were included in the final analysis

Ages

25 to 70 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion criteria * Age ≥25 years * Dentulous or partially dentulous * Underwent maxillectomy for oral neoplasm or CAM * Brown Class Ila, Ilb, or Iic maxillary defect involving the palate, nasal mucosa, and/or •paranasal sinuses requiring obturator rehabilitation * Exclusion criteria * Brown Class I defect * Bilateral maxillectomy (Brown Class Ild) * Brown Class III-IV/extensive defects * Orbital involvement/orbital exenteration * Defects extending beyond Brown classification * Transfacial surgical approach * Concomitant mandibulectomy * Complete edentulism * Severe trismus preventing definitive prosthesis fabrication * Tumor at a distant body site * Refusal to participate

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Conditions

The condition(s) this trial relates to.

lip and oral cavity carcinoma Zygomycosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mucormycosis

Contacts and locations

Locations

  • Mohammed A. El-Sawy

    Al Mansurah, 12345, Egypt

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