ClinicalTrials.gg
Status unknownNCT05678153ACU222Updated Mar 6, 2023

Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study

An observational study in Smoking and Orofacial Dysfunction, sponsored by Ahram Canadian University. Status unknown. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Ahram Canadian University · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
4 Years to 7 Years
Sex
All
01

Study summary

This study aims to investigate the orofacial dysfunction in children who are subjected to passive smoking and to correlate its results to their saliva cotinine levels

Read the detailed description

The participants will be recruited from the pedodontics outpatient clinic in the, Faculty of Oral and Dental Medicine, Ahram Canadian University, Egypt. The aim and the steps of the study will be explained to the guardian.

After obtaining the informed consent, the investigator will fill an administrative questionnaire, which includes parents and child's personal data, medical and dental history, a question inquiring if one of the parents smokes in the house, the frequency of smoking, smoking type, and number of cigarettes (if present).

Then, the examination of orofacial dysfunction will be evaluated by the investigator, using Nordic Orofacial Test - screen (NOT-S)

02

Conditions studied

  • Smoking
  • Orofacial Dysfunction

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03

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's planned enrollment of 20 is below the median of 114 across 69 observational studies indexed under Smoking.

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Lead sponsor

Ahram Canadian University is the lead sponsor of 71 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Cooperative Egyptian children aged from (four to seven) years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children who are free from any systematic disease, or genetic disorders that
  • Children whose families accept to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • Children whose parents quit smoking after the child was born.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • passive smokers children group (study group)

    children whose parents reported having one or more family members smokes indoors in the presence of the child

    Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)

  • non-passive smokers children group (control group)

    children whose parents reported not to have one or more family members smokes indoors in the presence of the child

    Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)

Interventions

  • Diagnostic testNordic Orofacial Test-Screen (NOT-S)

    screening tool to detect orofacial dysfunction

06

What researchers measure

Primary outcomes

  1. Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)

    deviation from normal functions of facial and oral structures

    Time frame: baseline record

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05678153
Lead sponsor
Ahram Canadian University
Responsible party
Mennat Allah Ashraf A.Elsabour (Primary investigator, Ahram Canadian University) — Principal investigator
First posted
Jan 10, 2023
Start date
May 1, 2023 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
Jun 15, 2023 (estimated)
Last update
Mar 6, 2023

Study contacts

Mennat Allah Abd-Elsabour, Master
Contact
menna.alkaram@acu.edu.eg
00201026022605
Mennat Allah Abd-Elsabour, Master
principal investigator · Ahram Canadian University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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