MucormycosisNCT06515743
Rehabilitation With an Obturator in Maxillary Defects
An observational study of Mucormycosis, run by Menoufia University at 1 site in Egypt.
Trial summary
During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Mucormycosis
- What is being tested?
- Obturator Prosthetic Rehabilitation
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Concomitant mandibulectomy
- Complete edentulism
- Severe trismus preventing definitive prosthesis fabrication
- Tumor at a distant body site
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Quality of Life After Rehabilitation With an Obturator in Maxillary Defects Due to COVID-19 Associated Mucormycosis and Oral Cancer.
During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies
Read the detailed description
Globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in India compared to developed countries, in a recent estimate of year 2019-2020.
Among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment
- Conditions
- Mucormycosis
- Being tested
- Obturator Prosthetic Rehabilitation
- Keywords
- Maxillary defects, Obturator prosthetic rehabilitation, Oral Health Impact Profile-14, Obturator Functioning Scale, Maxillofacial prosthetics
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator Prosthetic RehabilitationOther
Obturator prosthetic rehabilitation provided as part of routine clinical care following maxillectomy. Rehabilitation progressed through delayed surgical, transitional, and definitive obturator stages according to clinical healing and tissue stabilization. No intervention was assigned or modified for the purposes of this retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| Oral Neoplasm | Patients who underwent maxillectomy for oral neoplasms and subsequently received obturator prosthetic rehabilitation. Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects. Patient records from the Prosthodontic Department were retrospectively reviewed. OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators. Receives: Other: Obturator Prosthetic Rehabilitation | |
| COVID-19-Associated Mucormycosis (CAM) | Patients who underwent maxillectomy for COVID-19-associated mucormycosis (CAM) and subsequently received obturator prosthetic rehabilitation. Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects. Patient records from the Prosthodontic Department were retrospectively reviewed. OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators. Receives: Other: Obturator Prosthetic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Health-Related Quality of Life (OHIP-14) Across Obturator Rehabilitation Stages
Oral health-related quality of life was assessed using the validated Arabic version of the Oral Health Impact Profile-14 (OHIP-14). The total OHIP-14 score ranges from 0 to 56, with higher scores indicating poorer quality of life. Scores were retrospectively recorded at four assessment time points: after maxillectomy and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. Changes in OHIP-14 scores across rehabilitation stages were compared within and between the oral neoplasm and COVID-19-associated mucormycosis cohorts.
Measured: From after maxillectomy and before obturator rehabilitation through 1 week after insertion of the definitive obturator; assessments were performed at T1 (before obturator rehabilitation), T2 (1 week after delayed surgical obturator insertion), T3 (1 week
Secondary outcomes (1)
Obturator Functional Performance (Obturator Functioning Scale)
Obturator-related functional performance was assessed using the 15-item Obturator Functioning Scale (OFS), evaluating patient-reported difficulties related to speech, eating, and prosthesis appearance. The OFS was retrospectively recorded after insertion of the delayed surgical obturator, transitional obturator, and definitive obturator. Changes in OFS scores across these rehabilitation stages were compared within and between the oral neoplasm and COVID-19-associated mucormycosis cohorts.
Measured: From 1 week after insertion of the delayed surgical obturator through 1 week after insertion of the definitive obturator, with assessments at 1 week after insertion of the delayed surgical, transitional, and definitive obturators.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jun 2024
- Primary completion20 Sep 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed A. El-Sawy, PhD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515743
- Sponsor's protocol ID
- ADMNF-0020424
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared upon request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Life After Rehabilitation With an Obturator in Maxillary Defects Due to COVID-19 Associated Mucormycosis and Oral Cancer.
- ClinicalTrials.gov ID
- NCT06515743
- Acronym / sponsor ID
- ADMNF-0020424
- Conditions
- Mucormycosis
- Keywords
- Maxillary defects, Obturator prosthetic rehabilitation, Oral Health Impact Profile-14, Obturator Functioning Scale, Maxillofacial prosthetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies
Detailed description
Globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in India compared to developed countries, in a recent estimate of year 2019-2020.
Among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Neoplasm | – | Other: Obturator Prosthetic RehabilitationPatients who underwent maxillectomy for oral neoplasms and subsequently received obturator prosthetic rehabilitation. Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects. Patient records from the Prosthodontic Department were retrospectively reviewed. OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators. |
| COVID-19-Associated Mucormycosis (CAM) | – | Other: Obturator Prosthetic RehabilitationPatients who underwent maxillectomy for COVID-19-associated mucormycosis (CAM) and subsequently received obturator prosthetic rehabilitation. Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects. Patient records from the Prosthodontic Department were retrospectively reviewed. OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
Key exclusion criteria (11 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obturator Prosthetic RehabilitationObturator prosthetic rehabilitation provided as part of routine clinical care following maxillectomy. Rehabilitation progressed through delayed surgical, transitional, and definitive obturator stages according to clinical healing and tissue stabilization. No intervention was assigned or modified for the purposes of this retrospective study. | Other | COVID-19-Associated Mucormycosis (CAM), Oral Neoplasm |
Primary outcome
Change in Oral Health-Related Quality of Life (OHIP-14) Across Obturator Rehabilitation Stages
Time frame: From after maxillectomy and before obturator rehabilitation through 1 week after insertion of the definitive obturator; assessments were performed at T1 (before obturator rehabilitation), T2 (1 week after delayed surgical obturator insertion), T3 (1 week
Oral health-related quality of life was assessed using the validated Arabic version of the Oral Health Impact Profile-14 (OHIP-14). The total OHIP-14 score ranges from 0 to 56, with higher scores indicating poorer quality of life. Scores were retrospectively recorded at four assessment time points: after maxillectomy and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator. Changes in OHIP-14 scores across rehabilitation stages were compared within and between the oral neoplasm and COVID-19-associated mucormycosis cohorts.
1 secondary outcome
Obturator Functional Performance (Obturator Functioning Scale)
Time frame: From 1 week after insertion of the delayed surgical obturator through 1 week after insertion of the definitive obturator, with assessments at 1 week after insertion of the delayed surgical, transitional, and definitive obturators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. IPD can be shared upon request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A. El-Sawy, PhD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucormycosis, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Health-Related Quality of Life (OHIP-14) Across Obturator Rehabilitation Stages (time frame: From after maxillectomy and before obturator rehabilitation through 1 week after insertion of the definitive obturator; assessments were performed at T1 (before obturator rehabilitation), T2 (1 week after delayed surgical obturator insertion), T3 (1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.