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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05091814

Collaborator

National Cancer Institute (NCI) (NIH)

360

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillary Neoplasms	Radiation: radiotherapy

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 Design

Study Type:

Observational

Anticipated Enrollment :

360 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

% prevalence [1 year]
Trismus prevalence in percent

Secondary Outcome Measures

MMO [1 year]
maximum mouth opening

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo	Haram	Egypt	12511

Sponsors and Collaborators

Cairo University
National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Diaa Eldin Erfan, : Post-operative Prevalence of trismus in patients with maxillary cancer with and without radiation therapy in the Egyptian population.(a cross sectional study), Cairo University

ClinicalTrials.gov Identifier:

NCT05091814

Other Study ID Numbers:

10621

First Posted:

Oct 25, 2021

Last Update Posted:

Oct 25, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Diaa Eldin Erfan, : Post-operative Prevalence of trismus in patients with maxillary cancer with and without radiation therapy in the Egyptian population.(a cross sectional study), Cairo University

surgery , Trismus, Oral

Additional relevant MeSH terms:

Maxillary Neoplasms

Trismus

Study Results

No Results Posted as of Oct 25, 2021