Rehabilitation With an Obturator in Maxillary Defects

Menoufia University

Status: Completed

Conditions: Mucormycosis

Treatments: Other: Obturator Prosthetic Rehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT06515743

ADMNF-0020424

Details and patient eligibility

About

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

Full 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

Enrollment: 42 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

42 participants in 2 patient groups

Oral Neoplasm

Description:

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.

Treatment:

Other: Obturator Prosthetic Rehabilitation

COVID-19-Associated Mucormycosis (CAM)

Description:

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.

Treatment:

Other: Obturator Prosthetic Rehabilitation