NCT05784454

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:

  1. 1.In a group of Egyptian Children what is the prevalence of sleep bruxism?
  2. 2.What is the relation between sleep bruxism and screen time and sugar consumption?

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
349

participants targeted

Target at P75+ 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

March 5, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 5, 2023

Last Update Submit

March 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Sleep Bruxism in a group of Egyptian Children aged 6-8 years old

    Cross sectional Observational Study

    1 year

Secondary Outcomes (1)

  • Correlation between sleep bruxism and screen time and sugar consumption

    1 year

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected according to the mentioned eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34169271BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Mira A Kamal, Bachelor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mira A Kamal, Bachelor

CONTACT

Sherine Badr, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 27, 2023

Study Start

May 2, 2023

Primary Completion

September 2, 2023

Study Completion

November 2, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03