TMDNCT04618445
Prevalence of Temporomandibular Joint Disorders Among Egyptian University Undergraduate Students
An observational study of TMD and Bruxism, run by Cairo University at 1 site in Egypt.
Trial summary
This study will take place in Egypt. Undergraduate students from different faculties of the Egyptian Universities will participate. The study began in December 2020. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- some risk factors that might be correlated with TMD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Nov 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All undergraduate students in Egyptian Universities
Who may be able to join
- -Undergraduate students in Egyptian universities
- Age ranges from 18-45 years
- Males and females
Who cannot join
- school students
- students not living in egypt
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo, 11518
Iman Radi, PhD, 01001539613, iman.abdelwahab@dentistry.cu.edu.eg
Maram Taema, Masters, maram.taema@dentistry.cu.edu.eg
About this study
This study will take place in Egypt. Undergraduate students from different faculties of the Egyptian Universities will participate. The study began in December 2020.
Read the detailed description
Matching criteria and allocation ratio: The planned study a single arm cross sectional study, in which the prevalence of students of TMD will be reported. The association between TMD and other variables will be also studied. Therefore, no matching criteria or allocation ratio are required.
Variables It has been shown from literature that many variables are associated with TMD. It was therefore, decided to study the correlation between these variables with TMD among Egyptian population via a regression model once the assumption for regression analysis are satisfied. Binary variables are analyzed through logistic regression, while continuous data through a multivariable regression analysis. If one of the assumptions for regression analysis is violated, a subgroup analysis for each variable will be considered.
These Variables include gender, age, psychological stress, oral habits, parafunctional activities as gum chewing, previous dental treatments , previous trauma to jaws.
Data sources and management Data sources, the answered questionnaires and subsequent spread sheets will only be shared by the team members.
Addressing potential sources of bias Selection bias: an email will be sent to all the students through their university email addresses. Due to the COVID-19 situation only convenient sampling could be used. whenever possible printed questionnaires are handed to the students.
Quantitative variables: Handling of quantitative variables in the analyses None of the data is a continuous variable. All exposure factors are binary or categorical data. Therefore, no plans are set for simplifying continuous data or converting them into binary ones.
- Being tested
- some risk factors that might be correlated with TMD
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
some risk factors that might be correlated with TMDBehavioural
Fonesca questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Undergraduate students | prevalence of TMD among undergraduate students Receives: Behavioral: some risk factors that might be correlated with TMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of TMDs in Egyptian university students
Fonseca Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Dec 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Ahmed Taema, Cairo University
- Investigators
- Ramsis Magdy, BDS, Principal investigator, Cairo UniversityAzza Hussein, PhD, Study chair, Cairo UniversityIman Radi, PhD, Study director, Cairo UniversityMaram Taema, Master, Study director, Cairo UniversityAmr Nagib, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618445
- Sponsor's protocol ID
- 01112020
- Status last verified
- Aug 2021
- First submitted
- 1 Nov 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Temporomandibular Joint Disorders Among Egyptian University Undergraduate Students
- ClinicalTrials.gov ID
- NCT04618445
- Acronym / sponsor ID
- 01112020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 6 Nov 2020 (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 will take place in Egypt. Undergraduate students from different faculties of the Egyptian Universities will participate. The study began in December 2020.
Detailed description
Matching criteria and allocation ratio: The planned study a single arm cross sectional study, in which the prevalence of students of TMD will be reported. The association between TMD and other variables will be also studied. Therefore, no matching criteria or allocation ratio are required.
Variables It has been shown from literature that many variables are associated with TMD. It was therefore, decided to study the correlation between these variables with TMD among Egyptian population via a regression model once the assumption for regression analysis are satisfied. Binary variables are analyzed through logistic regression, while continuous data through a multivariable regression analysis. If one of the assumptions for regression analysis is violated, a subgroup analysis for each variable will be considered.
These Variables include gender, age, psychological stress, oral habits, parafunctional activities as gum chewing, previous dental treatments , previous trauma to jaws.
Data sources and management Data sources, the answered questionnaires and subsequent spread sheets will only be shared by the team members.
Addressing potential sources of bias Selection bias: an email will be sent to all the students through their university email addresses. Due to the COVID-19 situation only convenient sampling could be used. whenever possible printed questionnaires are handed to the students.
Quantitative variables: Handling of quantitative variables in the analyses None of the data is a continuous variable. All exposure factors are binary or categorical data. Therefore, no plans are set for simplifying continuous data or converting them into binary ones.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergraduate students | – | Behavioral: some risk factors that might be correlated with TMDprevalence of TMD among undergraduate students |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All undergraduate students in Egyptian Universities
Key inclusion criteria (3 listed)
- -Undergraduate students in Egyptian universities
- Age ranges from 18-45 years
- Males and females
Key exclusion criteria (2 listed)
- school students
- students not living in egypt
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 |
|---|---|---|
| some risk factors that might be correlated with TMDFonesca questionnaire | Behavioural | Undergraduate students |
Primary outcome
prevalence of TMDs in Egyptian university students
Time frame: 3 months
Fonseca Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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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.
Ramsis Magdy, BDS principal investigator
Cairo University
Azza Hussein, PhD study chair
Cairo University
Iman Radi, PhD study director
Cairo University
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 TMD and Bruxism, 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 3 inclusion and 2 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 4 Aug 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 Maram Taema, Master (01005487077, Maramtaema@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of TMDs in Egyptian university students (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.