Rehabilitation With an Obturator in Maxillary Defects

August 13, 2024 updated by: Mohammed El-Sawy, Menoufia University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 12345
        • Mohammed A. El-Sawy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49)
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Collaborators

Mansoura University

Investigators

  • Principal Investigator: Mohammed A. Elsawy, PhD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2024

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADMNF-0020424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD can be shared upon request from the corresponding author.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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