Skip to content

Rehabilitation With an Obturator in Maxillary Defects

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06515743
Enrollment
42
Registered
2024-07-23
Start date
2024-06-01
Completion date
2024-11-30
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucormycosis

Keywords

Maxillary defects, Obturator prosthetic rehabilitation, Oral Health Impact Profile-14, Obturator Functioning Scale, Maxillofacial prosthetics

Brief 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. 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

Interventions

OTHERObturator 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.

Sponsors

Menoufia University
Lead SponsorOTHER
Mansoura University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Oral Health-Related Quality of Life (OHIP-14) Across Obturator Rehabilitation StagesFrom 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 weekOral 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

MeasureTime frameDescription
Obturator Functional Performance (Obturator Functioning Scale)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.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohammed A. El-Sawy, PhD

Menoufia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026