Prevalence of Trismus in Patients With Maxillary Cancer W... | NCT05091814

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

NCT05091814

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Oct 25, 2021Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Maxillary Neoplasms

Interventions

radiotherapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2021Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Sep 26, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2021

Last Update Posted Date

Oct 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy (Yes or no) - Exercise (YES or NO)		with or without radiotherapy	Radiation: radiotherapy
MMO (in mm)		with or without radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiotherapy	Radiation	patients who recieved radiotherapy after surgical removal of the tumor	Radiotherapy (Yes or no) - Exercise (YES or NO)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% prevalence	Trismus prevalence in percent	1 year

Secondary Outcomes

Measure	Description	Time Frame
MMO	maximum mouth opening	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erfan	Contact	01111594776	12511	mohamed.diaa@dentistry.cu.edu.eg
Khashab	Contact	01006611525	12511	mohamed.elkhashab@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Gamal Ashour	National Cancer Institute (NCI)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo	Haram	12511	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30561067	Result	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.

ID	Term
D007573	Jaw Neoplasms
D012888	Skull Neoplasms
D001859	Bone Neoplasms
D009371	Neoplasms by Site