Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study (ACU222)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking; Orofacial Dysfunction
• Intervention / Treatment: Diagnostic test: Nordic Orofacial Test-Screen (NOT-S)

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)

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Mennat Allah Abd-Elsabour, Master; Phone Number: 00201026022605; Email: menna.alkaram@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); screening tool to detect orofacial dysfunction
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); screening tool to detect orofacial dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)	deviation from normal functions of facial and oral structures	baseline record

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Principal Investigator: Mennat Allah Abd-Elsabour, Master, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ACU 222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No