Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000345189
Ethics application status
Not required
Date submitted
25/02/2019
Date registered
5/03/2019
Date last updated
24/09/2019
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Awareness of Oral Hygiene among University Students
Scientific title
Oral Hygiene Awareness Among University Students in South Punjab
Secondary ID [1] 297522 0
None
Universal Trial Number (UTN)
U1111-1229-0464
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Hygiene 311730 0
Condition category
Condition code
Oral and Gastrointestinal 310356 310356 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
University students will be given questionnaire Comprising of 30 questions about their demographics, perception about oral hygiene, practice about maintaining oral hygiene and suggestions for maintaining oral hygiene. oral brushing behavior, paste and type of paste using, oral floss awareness. it will take maximum 5-10 minutes in filling of questionnaire. Different universities located in South Punjab, Pakistan will be visited and questionnaire from various departmental students will be filled.
Intervention code [1] 313761 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319227 0
Estimation of oral hygiene practice among university students in south Punjab, Pakistan through questionnaire based survey. It is validated questionnaire. This is modified form of questionnaire previously used by Shirazi et al., 2015.
Timepoint [1] 319227 0
At the end of March, 2019
Primary outcome [2] 319251 0
Estimation of awareness level of importance of oral hygiene through questionnaire served to each individual. It is validated questionnaire. This is modified form of questionnaire previously used by Shirazi et al., 2015.
Timepoint [2] 319251 0
End of March 2019
Primary outcome [3] 319252 0
Estimation of awareness of different modern techniques and practices for maintaining oral hygiene through questionnaire served to individuals. It is validated questionnaire. This is modified form of questionnaire previously used by Shirazi et al., 2015.
Timepoint [3] 319252 0
At the end of March, 2019
Secondary outcome [1] 367377 0
Estimation of attitude of students being involved in research activity through recollection of served questionnaires. It is validated questionnaire. This is modified form of questionnaire previously used by Shirazi et al., 2015.
Timepoint [1] 367377 0
At the end of March, 2019

Eligibility
Key inclusion criteria
1. Must be student in any of university of South Punjab, Pakistan
2. University should be located in South Punjab, Pakistan
3. All public and private university students are eligible to participate in this study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Universities located out of South Punjab, Pakistan.
2. Students not enrolled in universities at the time of questionnaire filling.
3. Unconscious and non-cooperative students
4. The students who are not willing to fill questionnaire
5. The students who are blind or having difficulty in filling of questionnaire

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
1. Chi square test for correlation.
2. Frequency distributions
3. Demographic analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
31/03/2019
Actual
31/03/2019
Date of last data collection
Anticipated
31/03/2019
Actual
31/03/2019
Sample size
Target
1152
Accrual to date
Final
314
Recruitment outside Australia
Country [1] 21309 0
Pakistan
State/province [1] 21309 0
PUNJAB

Funding & Sponsors
Funding source category [1] 302082 0
Self funded/Unfunded
Name [1] 302082 0
Jafir Hussain Shirazi
Country [1] 302082 0
Pakistan
Primary sponsor type
Individual
Name
Jafir Hussain Shirazi
Address
Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, Khawaja Fareed Campus, Railway Road, The Islamia University of Bahawalpur, Punjab, Pakistan
Country
Pakistan
Secondary sponsor category [1] 301899 0
None
Name [1] 301899 0
Address [1] 301899 0
Country [1] 301899 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 302761 0
Ethics committee address [1] 302761 0
Ethics committee country [1] 302761 0
Date submitted for ethics approval [1] 302761 0
Approval date [1] 302761 0
Ethics approval number [1] 302761 0

Summary
Brief summary
Oral hygiene is critical in determination of overall human health. Awareness about modern techniques, methods and ways is need of time. Students of universities are representatives of their families. Their perception and practice measurement will produce valuable observation about the society. Hence this study will be conducted.
Trial website
Trial related presentations / publications
Public notes
As this is only observational study and with out any intervention to the healthy human volunteers willing to fill questionnaire, hence this study needs no approval from committee of ethics. It involves four universities situated in south Punjab. Based on questionnaire, having no intervention, needs no ethics approval.

Contacts
Principal investigator
Name 91306 0
Mr Jafir Hussain Shirazi
Address 91306 0
Lecturer, Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, Khawaja Fareed Campus, Railway Road, The Islamia University of Bahawalpur, Punjab, Pakistan
Country 91306 0
Pakistan
Phone 91306 0
+92 336 0025271
Fax 91306 0
Email 91306 0
[email protected]
Contact person for public queries
Name 91307 0
Mr Jafir Hussain Shirazi
Address 91307 0
Lecturer, Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, Khawaja Fareed Campus, Railway Road, The Islamia University of Bahawalpur, Punjab, Pakistan
Country 91307 0
Pakistan
Phone 91307 0
+92 336 0025271
Fax 91307 0
Email 91307 0
[email protected]
Contact person for scientific queries
Name 91308 0
Mr Jafir Hussain Shirazi
Address 91308 0
Lecturer, Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, Khawaja Fareed Campus, Railway Road, The Islamia University of Bahawalpur, Punjab, Pakistan
Country 91308 0
Pakistan
Phone 91308 0
+92 336 0025271
Fax 91308 0
Email 91308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To preserve the privacy of the participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.