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

• Sponsor: Ahram Canadian University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05678153
• Collaborator: (none)
• Enrollment: 20
• Anticipated Duration (Months): 1.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Smoking; Orofacial Dysfunction	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 Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 15, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. orofacial dysfunction [baseline record]

   deviation from normal functions of facial and oral structures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mennat Allah Ashraf A.Elsabour, Primary investigator, Ahram Canadian University
• ClinicalTrials.gov Identifier: NCT05678153
• Other Study ID Numbers: ACU 222
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 10, 2023