Maxillary NeoplasmsNCT05091814
Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.
An observational study of Maxillary Neoplasms, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Neoplasms
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with maxillary cancer attending faculty of dentistry ,CU and the national cancer institute.
Who may be able to join
- patients with maxillary cancer
Who cannot join
- patients under 18 yrs .
- patients with TMJ disorders before surgery
- patients on chemotherapy
- - Tumors in other sites( Tongue , buccal mucosa , salivary glands, mandible)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Haram, 12511
mohamed erfan, 01111594776, mohamed.diaa@dentistry.cu.edu.eg
Mohamed khashab, 01006611525, mohamed.elkhashab@dentistry.cu.edu.eg
About this study
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)
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.
Read the 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)
- Conditions
- Maxillary Neoplasms
- Being tested
- radiotherapy
- Keywords
- surgery , Trismus, Oral
- Medical subject headings
- Maxillary Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
patients who recieved radiotherapy after surgical removal of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy (Yes or no) - Exercise (YES or NO) | with or without radiotherapy Receives: Radiation: radiotherapy | |
| MMO (in mm) | with or without radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
% prevalence
Trismus prevalence in percent
Measured: 1 year
Secondary outcomes (1)
MMO
maximum mouth opening
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mohamed Diaa Eldin Erfan, Cairo University
- Investigators
- Gamal Ashour, Study director, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091814
- Sponsor's protocol ID
- 10621
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the results of the study will be available at the college library for the researchers to benefit from.
Publications
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.
PubMed 30561067
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05091814
- Acronym / sponsor ID
- 10621
- Conditions
- Maxillary Neoplasms
- Keywords
- surgery , Trismus, Oral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy (Yes or no) - Exercise (YES or NO) | – | Radiation: radiotherapywith or without radiotherapy |
| MMO (in mm) | – | –with or without radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with maxillary cancer attending faculty of dentistry ,CU and the national cancer institute.
Key inclusion criteria (1 listed)
- patients with maxillary cancer
Key exclusion criteria (4 listed)
- patients under 18 yrs .
- patients with TMJ disorders before surgery
- patients on chemotherapy
- - Tumors in other sites( Tongue , buccal mucosa , salivary glands, mandible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapypatients who recieved radiotherapy after surgical removal of the tumor | Radiation | Radiotherapy (Yes or no) - Exercise (YES or NO) |
Primary outcome
% prevalence
Time frame: 1 year
Trismus prevalence in percent
1 secondary outcome
MMO
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Results publication: PubMed 30561067van 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.
- Individual participant dataSharing planned: Yes. the results of the study will be available at the college library for the researchers to benefit from.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Ashour study director
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Neoplasms, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erfan (01111594776 ext. 12511, mohamed.diaa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% prevalence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.