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

Maxillary Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091814
• Other study ID #: 10621
• Status: Recruiting
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: Erfan
• Phone: 01111594776
• Email: mohamed.diaa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Maxillary Neoplasms
• Trismus

Intervention

Radiation:
• radiotherapy
patients who recieved radiotherapy after surgical removal of the tumor

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Haram

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	National Cancer Institute (NCI)

Country where clinical trial is conducted

Egypt, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% prevalence	Trismus prevalence in percent	1 year
Secondary	MMO	maximum mouth opening	1 year