Rehabilitation With an Obturator in Maxillary Defects

NCT06515743 | Active Not Recruiting

• 1 other identifier: ADMNF-0020424
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Mucormycosis

Outcome Measures

Primary Outcomes (1)

• Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49)

  The OHIP-14 is a self-filled questionnaire developed by Locker and Slade that focuses on 7 dimensions of impact: functional limitation (questions #1,2), physical pain (questions #3,4), psychological discomfort (questions #5,6), physical disability (questions #7,8), psychological disability(question #9,10), social disability (question #11,12), and handicap (question #13,14), with participants being asked to respond according to the frequency of impact on a 5-point Likert scale coded as never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3), and very often (score 4). The OHIP-14 is a shorter version of the OHIP-49 but retains the original conceptual dimensions contained in the OHIP-49.

  6 months

Interventions

Delayed surgical obturator OTHER

Prosthetic rehabilitation after surgical treatment of mucormycosis is essential for the early restoration of oral function and facial esthetics which is performed by using the surgical obturator.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted on 60 patients who underwent maxillectomies between 2020 and 2023. All the patients of 25 years and above who consented for the study were included.

You may qualify if:

• \*Patients who underwent partial, subtotal and hemi-maxillectomy due to COVID-19-associated mucormycosis and who needed the prosthetic rehabilitation with delayed surgical obturator.

You may not qualify if:

• Patients who are unwilling for the study.
• Patients who underwent which bilateral maxillectomies.
• Patients having extensive palatal mucosal loss.

Sponsors & Collaborators

• Menoufia University: lead
• Mansoura University: collaborator

Study Sites (1)

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

Location

MeSH Terms

Conditions

Mucormycosis

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Mohammed A. Elsawy, PhD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Department of Prosthodontics, principle investigator

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 23, 2024
• Study Start: February 4, 2024
• Primary Completion: September 20, 2024
• Study Completion: November 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)