Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04582851 |
Other study ID # |
9102020 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2020 |
Est. completion date |
December 2022 |
Study information
Verified date |
August 2021 |
Source |
Cairo University |
Contact |
Maram Taema, masters |
Phone |
01005487077 |
Email |
maram.taema[@]dentistry.cu.edu.eg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The study will take place in Egypt. Postgraduate students from different faculties of the
Egyptian Universities will participate. The study will begin in Decemberr 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. Gender, Age, Psychological stress, non-nutritional oral
habits as nail biting, lip biting, object biting and grinding of teeth (bruxism & clenching),
Para-functional habits, such as intensive gum chewing, leaning of the chin on the hand and
mouth breathing , previous dental treatment and previous jaw trauma will be all studied.
Data sources and management Data sources, the answered questionnaires and subsequent spread
sheets will only be shared by the team members.
ddressing potential sources of bias Selection bias: Sampling will be convenient sampling,
Questionnaires will be handed to the students, otherwise an email will be sent to all the
students through their university email addresses if COVID-19 situation prevails.
Statistical methods Statistical methods
All confounders, effect modifiers and exposures will be controlled for by crude and adjusted
regression analyses, where the primary analysis will be the adjusted one. Failure to do so as
a result of violating principles of a regression model will call for a subgroup analysis,
where a student t test will be used for the comparison between the subgroups.
It is also planned to study the interactions between the variables via ANOVA test if the data
show normal distribution.
Participants with missing data will be excluded.
- Cross-sectional study-Since the planned sampling method is cluster sampling, where the
design effect factor becomes greater than 1.
Sensitivity of the results to adjusted and crude analysis will be done.