Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.

October 12, 2021 updated by: Mohamed Diaa Eldin Erfan, Cairo University

: Post-operative Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.(a Cross Sectional Study)

This study aims at evaluating the prevalence of trismus among maxillary cancer patients in the Egyptian population and the effect of radiotherapy on the occurrence of trismus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The enrolled participants who meet the eligibility criteria and signed the informed consent of participation in the study will undergo clinical examination to determine the maximum mouth opening after performing surgery only and /or after radiotherapy in case of adjuvant therapy

the maximum mouth opening will be measured in (mm) by using a digital caliper device and will be recorded in the patient sheet,

reading of less than 35mm will be considered trismus while above 35mm or more will be considered normal (NO trismus)

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with maxillary cancer attending faculty of dentistry ,CU and the national cancer institute.

Description

Inclusion Criteria:

  • patients with maxillary cancer

Exclusion Criteria:

  • patients under 18 yrs .
  • patients with TMJ disorders before surgery
  • patients on chemotherapy
  • - Tumors in other sites( Tongue , buccal mucosa , salivary glands, mandible)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiotherapy (Yes or no) - Exercise (YES or NO)
with or without radiotherapy
Radiation: radiotherapy
patients who recieved radiotherapy after surgical removal of the tumor
MMO (in mm)
with or without radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% prevalence
Time Frame: 1 year
Trismus prevalence in percent
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMO
Time Frame: 1 year
maximum mouth opening
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Director: Gamal Ashour, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (ACTUAL)

October 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the results of the study will be available at the college library for the researchers to benefit from.

IPD Sharing Time Frame

1-2 years

IPD Sharing Access Criteria

Free access

IPD Sharing Supporting Information Type

  • CSR

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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