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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05091814
Other study ID # 10621
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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