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

NCT ID: NCT05091814

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Maxillary Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

with or without radiotherapy

radiotherapy

Intervention Type RADIATION

patients who recieved radiotherapy after surgical removal of the tumor

MMO (in mm)

with or without radiotherapy

No interventions assigned to this group

Interventions

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radiotherapy

patients who recieved radiotherapy after surgical removal of the tumor

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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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)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamal Ashour

Role: STUDY_DIRECTOR

National Cancer Institute (NCI)

Locations

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Cairo University

Cairo, Haram, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Erfan

Role: CONTACT

01111594776 ext. 12511

Khashab

Role: CONTACT

01006611525 ext. 12511

Facility Contacts

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mohamed erfan

Role: primary

01111594776

Mohamed khashab

Role: backup

01006611525

References

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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.

Reference Type RESULT
PMID: 30561067 (View on PubMed)

Other Identifiers

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10621

Identifier Type: -

Identifier Source: org_study_id