Prevalance of Sleep Bruxism Among a Group of Egyptian Chi... | NCT05784454

Studies
Prevalance of Sleep Bruxism Among a Group of Egyptian Children

NCT05784454

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 29, 2023Actual

Enrollment

349Estimated

Phase

Not provided

Conditions

Sleep Bruxism

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2023Estimated

Primary Completion Date

Sep 2, 2023Estimated

Completion Date

Nov 2, 2023Estimated

First Submitted Date

Mar 5, 2023

First Submission Date that Met QC Criteria

Mar 11, 2023

First Posted Date

Mar 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2023

Last Update Posted Date

Mar 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

349Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old	Cross sectional Observational Study	1 year

Secondary Outcomes

Measure	Description	Time Frame
Correlation between sleep bruxism and screen time and sugar consumption	Cross sectional Observational Study	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Participants will be selected according to the mentioned eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mira A Kamal, Bachelor	Contact	01271912221		miraashraf@dentistru.cu.edu.eg
Sherine Badr, Professor	Contact	01001408341		sherinebadr@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Mira A Kamal, Bachelor	Cairo University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34169271	Background	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.

ID	Term
D002012	Bruxism
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D020447	Parasomnias