NCT05678153

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

December 23, 2022

Last Update Submit

March 3, 2023

Conditions

SmokingOrofacial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)

    deviation from normal functions of facial and oral structures

    baseline record

Study Arms (2)

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

Nordic Orofacial Test-Screen (NOT-S)DIAGNOSTIC_TEST

screening tool to detect orofacial dysfunction

non-passive smokers children group (control group)passive smokers children group (study group)

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mennat Allah Abd-Elsabour, Master

    Ahram Canadian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mennat Allah Abd-Elsabour, Master

CONTACT

00201026022605menna.alkaram@acu.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 10, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 15, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03