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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04618445
Other study ID # 01112020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date November 1, 2022

Study information

Verified date August 2021
Source Cairo University
Contact Maram Taema, Master
Phone 01005487077
Email Maramtaema@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date November 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. -Undergraduate students in Egyptian universities 2. Age ranges from 18-45 years 3. Males and females Exclusion criteria 1. school students 2. students not living in egypt

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
some risk factors that might be correlated with TMD
Fonesca questionnaire

Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of TMDs in Egyptian university students Fonseca Questionnaire 3 months
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