SmokingACU222NCT05678153
Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study
An observational study of Smoking and Orofacial Dysfunction, run by Ahram Canadian University.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Orofacial Dysfunction
- What is being tested?
- Nordic Orofacial Test-Screen (NOT-S)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cooperative Egyptian children aged from (four to seven) years.
Who may be able to join
- Children who are free from any systematic disease, or genetic disorders that
- Children whose families accept to participate in this study.
Who cannot join
- Children whose parents quit smoking after the child was born.
Trial locations and contacts
No sites are listed yet.
About this study
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)
- Conditions
- Smoking, Orofacial Dysfunction
- Being tested
- Nordic Orofacial Test-Screen (NOT-S)
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic Orofacial Test-Screen (NOT-S)Diagnostic test
screening tool to detect orofacial dysfunction
| Study group | Role | What they receive |
|---|---|---|
| passive smokers children group (study group) | children whose parents reported having one or more family members smokes indoors in the presence of the child Receives: 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 Receives: Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)
deviation from normal functions of facial and oral structures
Measured: baseline record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Ashraf A.Elsabour, Ahram Canadian University
- Investigators
- Mennat Allah Abd-Elsabour, Master, Principal investigator, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678153
- Sponsor's protocol ID
- ACU 222
- Acronym
- ACU222
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Smoking on Orofacial Dysfunction Among a Group of Egyptian Children: A Cohort Study
- ClinicalTrials.gov ID
- NCT05678153
- Acronym / sponsor ID
- ACU222 / ACU 222
- Conditions
- Smoking, Orofacial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| passive smokers children group (study group) | – | Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)children whose parents reported having one or more family members smokes indoors in the presence of the child |
| non-passive smokers children group (control group) | – | Diagnostic Test: Nordic Orofacial Test-Screen (NOT-S)children whose parents reported not to have one or more family members smokes indoors in the presence of the child |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cooperative Egyptian children aged from (four to seven) years.
Key inclusion criteria (2 listed)
- Children who are free from any systematic disease, or genetic disorders that
- Children whose families accept to participate in this study.
Key exclusion criteria (1 listed)
- Children whose parents quit smoking after the child was born.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic Orofacial Test-Screen (NOT-S)screening tool to detect orofacial dysfunction | Diagnostic test | non-passive smokers children group (control group), passive smokers children group (study group) |
Primary outcome
Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen)
Time frame: baseline record
deviation from normal functions of facial and oral structures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mennat Allah Abd-Elsabour, Master principal investigator
Ahram Canadian University
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Orofacial Dysfunction, run by Ahram Canadian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennat Allah Abd-Elsabour, Master (00201026022605, menna.alkaram@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orofacial Dysfunction (measured using Nordic Orofacial Test-Screen) (time frame: baseline record). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.