BruxismNCT03006133
Prevalence of Bruxism in a Group of Preschool Egyptian Children
An observational study of Bruxism, run by Cairo University at 1 site in Egypt.
Trial summary
The protocol is to show the prevalence of bruxism among a group of Egyptian children Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- How many people
- 362 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Nov 2017
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: preschool Egyptian children
Who may be able to join
- Cooperative children from 3-6 years
- Children without any Medical problems
- Children of families who accept to participate in the study
Who cannot join
- 1- Children with caries in posterior teeth
Trial locations and contacts
1 site in 1 country.
Randa Youssef, Ass.Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Manal Ahmed
Cairo Governorate, Manial, 11211
Manal Elsayed, Ass.Prof., +201227332259, manal.agha@hotmail.com
About this study
The protocol is to show the prevalence of bruxism among a group of Egyptian children
Read the detailed description
Many studies are done on children to show the prevalence of bruxism among different ages , reports of prevalence range from 8-31% in the general population, the prevalence of bruxism in Egyptian children is unknown. Several symptoms are commonly associated with bruxism, including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal symptoms, and therefore people may not be aware of the condition,so this study is important to determine the prevalence of bruxism of preschool Egyptian children
- Conditions
- Bruxism
- Medical subject headings
- Bruxism
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Bruxism
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 posted30 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Wafik Ismael Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006133
- Sponsor's protocol ID
- CEBC-CU-2016-12-171
- Status last verified
- Feb 2017
- First submitted
- 27 Dec 2016
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Bruxism in a Group of Preschool Egyptian Children
- ClinicalTrials.gov ID
- NCT03006133
- Acronym / sponsor ID
- CEBC-CU-2016-12-171
- Conditions
- Bruxism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- 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 protocol is to show the prevalence of bruxism among a group of Egyptian children
Detailed description
Many studies are done on children to show the prevalence of bruxism among different ages , reports of prevalence range from 8-31% in the general population, the prevalence of bruxism in Egyptian children is unknown. Several symptoms are commonly associated with bruxism, including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal symptoms, and therefore people may not be aware of the condition,so this study is important to determine the prevalence of bruxism of preschool Egyptian children
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- preschool Egyptian children
Key inclusion criteria (3 listed)
- Cooperative children from 3-6 years
- Children without any Medical problems
- Children of families who accept to participate in the study
Key exclusion criteria (1 listed)
- 1- Children with caries in posterior teeth
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 Bruxism
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 10 Feb 2017.
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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.
Randa Youssef, Ass.Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, run by Cairo University at 1 site in Egypt.
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 3 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Manal Ahmed, Ass.Prof. (+201227332259, manal.agha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Bruxism (time frame: 1 year). 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 10 Feb 2017.