Sleep BruxismNCT05784454
Prevalance of Sleep Bruxism Among a Group of Egyptian Children
An observational study of Sleep Bruxism, run by Cairo University.
Trial summary
The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are: 1. In a group of Egyptian Children what is the prevalence of sleep bruxism? 2. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism
- How many people
- 349 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2023to 2 Nov 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be selected according to the mentioned eligibility criteria
Who may be able to join
- Positive Subject acceptance for participation in the study
- Healthy children aged 6-8 years old
- Both genders
- The presence of mixed dentition with permnant first molar erupted
Who cannot join
- Children with mental or neurological disorders
- Children with systemic disorders
- Children who use medications that could not interfere with the central nervous system
- Children suffering from sleep disorders. e.g: Obstructive Sleep Apnea
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Sleep Bruxism in a Group of Egyptian Children and Its Relation to Screen Time and Sugar Consumption
The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are:
- In a group of Egyptian Children what is the prevalence of sleep bruxism?
- What is the relation between sleep bruxism and screen time and sugar consumption?
Read the detailed description
Parents of a group of Egyptian Children aged 6-8 years old will be asked to fill
- An informed Consent
- Children Sleep Habit Questionnaire to detect the presence of sleep bruxism or not?
- Food Frequency Questionnaire of Health Behaviour Sugar Consumption questionnaire
- Leisure Time, Television Use, Computer Use Sections of the Health Behaviour Sugar Consumption Questionnaire
- Conditions
- Sleep Bruxism
- Medical subject headings
- Sleep Bruxism
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old
Cross sectional Observational Study
Measured: 1 year
Secondary outcomes (1)
Correlation between sleep bruxism and screen time and sugar consumption
Cross sectional Observational Study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start2 May 2023 (estimated)
- Primary completion2 Sep 2023 (estimated)
- Study completion2 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 349 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mira Ashraf Kamal, Cairo University
- Investigators
- Mira A Kamal, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784454
- Sponsor's protocol ID
- Sleep Bruxism in Children
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Restrepo C, Santamaria A, Manrique R. Sleep bruxism in children: relationship with screen-time and sugar consumption. Sleep Med X. 2021 Apr 24;3:100035. doi: 10.1016/j.sleepx.2021.100035. eCollection 2021 Dec.
PubMed 34169271
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Bruxism in a Group of Egyptian Children and Its Relation to Screen Time and Sugar Consumption
- ClinicalTrials.gov ID
- NCT05784454
- Acronym / sponsor ID
- Sleep Bruxism in Children
- Conditions
- Sleep Bruxism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 349 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (estimated)
- Primary completion
- 2 Sep 2023 (estimated)
- Study completion
- 2 Nov 2023 (estimated)
- First posted
- 27 Mar 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.
The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are:
- In a group of Egyptian Children what is the prevalence of sleep bruxism?
- What is the relation between sleep bruxism and screen time and sugar consumption?
Detailed description
Parents of a group of Egyptian Children aged 6-8 years old will be asked to fill
- An informed Consent
- Children Sleep Habit Questionnaire to detect the presence of sleep bruxism or not?
- Food Frequency Questionnaire of Health Behaviour Sugar Consumption questionnaire
- Leisure Time, Television Use, Computer Use Sections of the Health Behaviour Sugar Consumption Questionnaire
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be selected according to the mentioned eligibility criteria
Key inclusion criteria (4 listed)
- Positive Subject acceptance for participation in the study
- Healthy children aged 6-8 years old
- Both genders
- The presence of mixed dentition with permnant first molar erupted
Key exclusion criteria (4 listed)
- Children with mental or neurological disorders
- Children with systemic disorders
- Children who use medications that could not interfere with the central nervous system
- Children suffering from sleep disorders. e.g: Obstructive Sleep Apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old
Time frame: 1 year
Cross sectional Observational Study
1 secondary outcome
Correlation between sleep bruxism and screen time and sugar consumption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 34169271Restrepo C, Santamaria A, Manrique R. Sleep bruxism in children: relationship with screen-time and sugar consumption. Sleep Med X. 2021 Apr 24;3:100035. doi: 10.1016/j.sleepx.2021.100035. eCollection 2021 Dec.
- The link is to a similar article but with different age groups and different setting placeLink provided by the sponsor.
- 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.
Mira A Kamal, Bachelor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Bruxism, run by Cairo 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 4 inclusion and 4 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 29 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 Mira A Kamal, Bachelor (01271912221, miraashraf@dentistru.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784454, which also lists 1 linked publication.
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 29 Mar 2023.