Rehabilitation With an Obturator in Maxillary Defects

August 20, 2026 updated by: Mohammed El-Sawy, Menoufia University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt, 12345
        • Mohammed A. El-Sawy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Obturator Prosthetic Rehabilitation
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.
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.
Other: Obturator Prosthetic Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Collaborators

Mansoura University

Investigators

  • Principal Investigator: Mohammed A. El-Sawy, PhD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADMNF-0020424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD can be shared upon request from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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