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

NCT05091814 | Unknown DMC

• 1 other identifier: 10621
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Neoplasms

Keywords

surgery , Trismus, Oral

Outcome Measures

Primary Outcomes (1)

• % prevalence

  Trismus prevalence in percent

  1 year

Secondary Outcomes (1)

• MMO

  1 year

Study Arms (2)

Radiotherapy (Yes or no) - Exercise (YES or NO)

with or without radiotherapy

Radiation: radiotherapy

MMO (in mm)

with or without radiotherapy

Interventions

radiotherapy RADIATION

patients who recieved radiotherapy after surgical removal of the tumor

Radiotherapy (Yes or no) - Exercise (YES or NO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patients with maxillary cancer

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cairo University

Cairo, Haram, 12511, Egypt

RECRUITING

Related Publications (1)

• van der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.

  PMID: 30561067 RESULT

MeSH Terms

Conditions

Maxillary Neoplasms; Trismus

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Maxillary Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gamal Ashour

  National Cancer Institute (NCI)

  STUDY DIRECTOR

Central Study Contacts

Erfan

CONTACT

01111594776; mohamed.diaa@dentistry.cu.edu.eg

Khashab

CONTACT

01006611525; mohamed.elkhashab@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : Post-operative Prevalence of trismus in patients with maxillary cancer with and without radiation therapy in the Egyptian population.(a cross sectional study)

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 1-2 years
• Access Criteria: Free access

Locations

EG (1)