Rehabilitation With an Obturator in Maxillary Defects

Active, not recruiting

• Conditions: Mucormycosis

• Registration Number: NCT06515743
• Lead Sponsor: Menoufia University

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

Study Timeline

• Study Start: 2024-02-04
• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Study First Posted: 2024-07-23
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-09-20
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49)	6 months	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.

Trial Locations

Locations (1)

Mohammed A. El-Sawy; 🇪🇬 Mansoura, Egypt