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Clinical Trials/NCT05310162
NCT05310162UnknownNot Applicable

Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children

CES University0 sites80 target enrollmentStarted: April 11, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
80
Primary Endpoint
Frecuency of sleep bruxism

Study Overview

Brief Summary

Excess consumption of refined sugar and increased use of recreational screen time are risk factors for alterations in the quality of life that have been associated with sleep bruxism in children and that compromise the same mechanisms of alteration of the reward system in the brain. Therefore, the question of this research is: What is the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in children? The general objective of the research is to evaluate the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in 84 children who attend the pediatric dentistry postgraduate clinic of the CES University and the private consultation Dr. Claudia Restrepo and Dr. Adriana Santamaría. The frequency of sleep bruxism will be evaluated with the translated and validated Spanish version of the Children's Sleep Habits Questionnaire (CSHQ), which will be answered by the parents. The consumption of added sugar will be evaluated with the version translated into Spanish of the Health Behavior in School-Aged Children - Food-Frequency Questionnaire (HBSC-FFQ). The time on screens will be recorded through the parents' report, of the time in hours that the child spends using electronic media in a recreational way each weekday for a week and each weekend day for a week.

A decrease in the frequency of sleep bruxism is expected to be found by reducing sugar consumption and screen time in the children evaluated.

The results of this study will be presented at the IADR, ACFO, ACOP and CES University research meetings and will be published in a peer-reviewed scientific journal in category Q1.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Children who eat breakfast, lunch and dinner at home.
  • Children whose feeding and habits management (upbringing) is in charge of the same group of representative adults.
  • Children who live with their parents.
  • Children attending the consultation for the first time.

Exclusion Criteria

  • Symptoms of respiratory disorders reported by parents in the CSHQ.
  • Food allergies.
  • Special diet restrictions.
  • Developmental disorder influencing diet or weight.
  • Basic endocrinological diseases.
  • Being under endocrinological treatment.
  • Previously diagnosed sleep disorders.
  • Children who miss more than two assigned appointments.
  • Parents of children who withdraw informed consent.
  • Children who are diagnosed during the study with respiratory disorders.
  • Children who are diagnosed during the study with food allergies.
  • Children who for personal reasons cannot continue in the study.

Outcomes

Primary Outcomes

Frecuency of sleep bruxism

Time Frame: 8 weeks

Report from the parents in the CSHQ with values of usually, some times and no/rarely

Secondary Outcomes

  • Frecuency of added sugar consumption(8 weeks)
  • Screen time(8 weeks)

Investigators

Sponsor
CES University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia Cecilia Restrepo Serna

CES-LPH research group director

CES University

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