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Completed

NCT Number: NCT06515743

Rehabilitation With an Obturator in Maxillary Defects

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

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Key information

Conditions

Mucormycosis Bacterial Infections and Mycoses Infections Mycoses Zygomycosis

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Obturator Prosthetic Rehabilitation

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Comparison of Quality of Life After Rehabilitation With an Obturator in Maxillary Defects Due to COVID-19 Associated Mucormycosis and Oral Cancer.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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