Sleep Bruxism, ChildhoodNCT05310162
Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
A study testing Food, fun and family and Counseling in people with Sleep Bruxism, Childhood, run by CES University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Sleep Bruxism, Childhood
- What is being tested?
- Food, fun and family and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2022to 5 May 2023
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Sleep Bruxism, Childhood
- Being tested
- Food, fun and family, Counseling
- Keywords
- Children, Sleep bruxism, Added sugar, Screen time
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food, fun and familyBehavioural
Also called FFF
The intervention consists of a series of change of habits in the way children eat, the reduction of the recreational time of screens and healthy habits of physical activity. This intervention, which is called "Food, Fun \& Family (FFF)", is aimed at parents and has been shown to be effective in reducing the consumption of "empty calories" by children. It teaches parents skills to reduce their daily energy intake of added sugars and saturated fats, it also seeks to reduce screen time.
The intervention contains information and recommendations, through guides, in which precise instructions are given about how to maintain a healthy environment at home.
CounselingBehavioural
Simple verbal instructions will be given in the consultation to reduce the time of use of screens and refined sugar.
For refined sugar reduction, parents will be told to avoid sugary drinks, add sugar to drinks (juices, milk, etc.), and avoid snacks and sweets. It will also be indicated that the screen time should be less than two hours a day and in no case use them two hours before sleeping.
| Study group | Role | What they receive |
|---|---|---|
| Food, fun and family | Experimental | This intervention aims to change eating and screen time habits in children to decrease the amount of added sugar consumed and the time spent using recreational screens, this with guides and precise instructions given to the parents to have a healthier lifestyle. Receives: Behavioral: Food, fun and family |
| Counseling | Active comparator | The parents will receive simple verbal instructions to reduce the consumption of added sugar and recreational screen time, giving advice on which foods to avoid and the amount of time permitted for the use of screens. Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frecuency of sleep bruxism
Report from the parents in the CSHQ with values of usually, some times and no/rarely
Measured: 8 weeks
Secondary outcomes (2)
Frecuency of added sugar consumption
Report from the parents with the Spanish translated version of the HBSC-FFQ with values of never, less than one time a week, once a week, four days a week, five to six times a week, once a day every day, more than one a day
Measured: 8 weeks
Screen time
Report from the parents of time in hours spent in front of audiovisuals, every day of the week during a week and each day of the weekend during a weekend
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start11 Apr 2022 (estimated)
- Primary completion10 Dec 2022 (estimated)
- Study completion5 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Sleep Bruxism, ChildhoodStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Cecilia Restrepo Serna, CES University
- Investigators
- Claudia C Restrepo, PHD, Principal investigator, CES LPH research groupRuben D Manrique, PHD, Study chair, CES LPH research group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310162
- Sponsor's protocol ID
- 1017
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
PubMed 29926505Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24.
PubMed 23700983Fisberg M, Kovalskys I, Gomez G, Rigotti A, Sanabria LYC, Garcia MCY, Torres RGP, Herrera-Cuenca M, Zimberg IZ, Koletzko B, Pratt M, Aznar LAM, Guajardo V, Fisberg RM, Sales CH, Previdelli AN; ELANS Study Group. Total and Added Sugar Intake: Assessment in Eight Latin American Countries. Nutrients. 2018 Mar 22;10(4):389. doi: 10.3390/nu10040389.
PubMed 29565308Wittekind A, Walton J. Worldwide trends in dietary sugars intake. Nutr Res Rev. 2014 Dec;27(2):330-45. doi: 10.1017/S0954422414000237.
PubMed 25623085Newens KJ, Walton J. A review of sugar consumption from nationally representative dietary surveys across the world. J Hum Nutr Diet. 2016 Apr;29(2):225-40. doi: 10.1111/jhn.12338. Epub 2015 Oct 10.
PubMed 26453428Ervin RB, Kit BK, Carroll MD, Ogden CL. Consumption of added sugar among U.S. children and adolescents, 2005-2008. NCHS Data Brief. 2012 Mar;(87):1-8.
PubMed 22617043Lissak G. Adverse physiological and psychological effects of screen time on children and adolescents: Literature review and case study. Environ Res. 2018 Jul;164:149-157. doi: 10.1016/j.envres.2018.01.015. Epub 2018 Feb 27.
PubMed 29499467Ramos-Lopez O, Panduro A, Rivera-Iniguez I, Roman S. Dopamine D2 receptor polymorphism (C957T) is associated with sugar consumption and triglyceride levels in West Mexicans. Physiol Behav. 2018 Oct 1;194:532-537. doi: 10.1016/j.physbeh.2018.07.004. Epub 2018 Jul 4.
PubMed 30008437Yen JY, Ko CH, Yen CF, Wu HY, Yang MJ. The comorbid psychiatric symptoms of Internet addiction: attention deficit and hyperactivity disorder (ADHD), depression, social phobia, and hostility. J Adolesc Health. 2007 Jul;41(1):93-8. doi: 10.1016/j.jadohealth.2007.02.002. Epub 2007 Apr 12.
PubMed 17577539Del-Ponte B, Quinte GC, Cruz S, Grellert M, Santos IS. Dietary patterns and attention deficit/hyperactivity disorder (ADHD): A systematic review and meta-analysis. J Affect Disord. 2019 Jun 1;252:160-173. doi: 10.1016/j.jad.2019.04.061. Epub 2019 Apr 10.
PubMed 30986731Restrepo C, Manfredini D, Lobbezoo F. Sleep behaviors in children with different frequencies of parental-reported sleep bruxism. J Dent. 2017 Nov;66:83-90. doi: 10.1016/j.jdent.2017.08.005. Epub 2017 Aug 12.
PubMed 28807776Bach SL, Moreira FP, Goettems ML, Brancher LC, Oses JP, da Silva RA, Jansen K. Salivary cortisol levels and biological rhythm in schoolchildren with sleep bruxism. Sleep Med. 2019 Feb;54:48-52. doi: 10.1016/j.sleep.2018.09.031. Epub 2018 Oct 28.
PubMed 30529777Velez AL, Restrepo CC, Pelaez-Vargas A, Gallego GJ, Alvarez E, Tamayo V, Tamayo M. Head posture and dental wear evaluation of bruxist children with primary teeth. J Oral Rehabil. 2007 Sep;34(9):663-70. doi: 10.1111/j.1365-2842.2007.01742.x.
PubMed 17716265Souto-Souza D, Mourao PS, Barroso HH, Douglas-de-Oliveira DW, Ramos-Jorge ML, Falci SGM, Galvao EL. Is there an association between attention deficit hyperactivity disorder in children and adolescents and the occurrence of bruxism? A systematic review and meta-analysis. Sleep Med Rev. 2020 Oct;53:101330. doi: 10.1016/j.smrv.2020.101330. Epub 2020 May 19.
PubMed 32554210Turkoglu S, Akca OF, Turkoglu G, Akca M. Psychiatric disorders and symptoms in children and adolescents with sleep bruxism. Sleep Breath. 2014 Sep;18(3):649-54. doi: 10.1007/s11325-013-0928-y. Epub 2013 Dec 28.
PubMed 24371001
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
- ClinicalTrials.gov ID
- NCT05310162
- Acronym / sponsor ID
- 1017
- Conditions
- Sleep Bruxism, Childhood
- Keywords
- Children, Sleep bruxism, Added sugar, Screen time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Study start
- 11 Apr 2022 (estimated)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 4 Apr 2022 (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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food, fun and family | Experimental | Behavioral: Food, fun and familyThis intervention aims to change eating and screen time habits in children to decrease the amount of added sugar consumed and the time spent using recreational screens, this with guides and precise instructions given to the parents to have a healthier lifestyle. |
| Counseling | Active comparator | Behavioral: CounselingThe parents will receive simple verbal instructions to reduce the consumption of added sugar and recreational screen time, giving advice on which foods to avoid and the amount of time permitted for the use of screens. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Symptoms of respiratory disorders reported by parents in the CSHQ.
- Food allergies.
- Special diet restrictions.
- Developmental disorder influencing diet or weight.
- Basic endocrinological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food, fun and familyAlso: FFFThe intervention consists of a series of change of habits in the way children eat, the reduction of the recreational time of screens and healthy habits of physical activity. This intervention, which is called "Food, Fun \& Family (FFF)", is aimed at parents and has been shown to be effective in reducing the consumption of "empty calories" by children. It teaches parents skills to reduce their daily energy intake of added sugars and saturated fats, it also seeks to reduce screen time. The intervention contains information and recommendations, through guides, in which precise instructions are given about how to maintain a healthy environment at home. | Behavioural | Food, fun and family |
| CounselingSimple verbal instructions will be given in the consultation to reduce the time of use of screens and refined sugar. For refined sugar reduction, parents will be told to avoid sugary drinks, add sugar to drinks (juices, milk, etc.), and avoid snacks and sweets. It will also be indicated that the screen time should be less than two hours a day and in no case use them two hours before sleeping. | Behavioural | Counseling |
Primary outcome
Frecuency of sleep bruxism
Time frame: 8 weeks
Report from the parents in the CSHQ with values of usually, some times and no/rarely
2 secondary outcomes
Frecuency of added sugar consumption
Time frame: 8 weeks
Screen time
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 29926505Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
- Background: PubMed 23700983Manfredini D, Restrepo C, Diaz-Serrano K, Winocur E, Lobbezoo F. Prevalence of sleep bruxism in children: a systematic review of the literature. J Oral Rehabil. 2013 Aug;40(8):631-42. doi: 10.1111/joor.12069. Epub 2013 May 24.
- Background: PubMed 29565308Fisberg M, Kovalskys I, Gomez G, Rigotti A, Sanabria LYC, Garcia MCY, Torres RGP, Herrera-Cuenca M, Zimberg IZ, Koletzko B, Pratt M, Aznar LAM, Guajardo V, Fisberg RM, Sales CH, Previdelli AN; ELANS Study Group. Total and Added Sugar Intake: Assessment in Eight Latin American Countries. Nutrients. 2018 Mar 22;10(4):389. doi: 10.3390/nu10040389.
- Background: PubMed 25623085Wittekind A, Walton J. Worldwide trends in dietary sugars intake. Nutr Res Rev. 2014 Dec;27(2):330-45. doi: 10.1017/S0954422414000237.
- Background: PubMed 26453428Newens KJ, Walton J. A review of sugar consumption from nationally representative dietary surveys across the world. J Hum Nutr Diet. 2016 Apr;29(2):225-40. doi: 10.1111/jhn.12338. Epub 2015 Oct 10.
- Background: PubMed 22617043Ervin RB, Kit BK, Carroll MD, Ogden CL. Consumption of added sugar among U.S. children and adolescents, 2005-2008. NCHS Data Brief. 2012 Mar;(87):1-8.
- Background: PubMed 29499467Lissak G. Adverse physiological and psychological effects of screen time on children and adolescents: Literature review and case study. Environ Res. 2018 Jul;164:149-157. doi: 10.1016/j.envres.2018.01.015. Epub 2018 Feb 27.
- Background: PubMed 30008437Ramos-Lopez O, Panduro A, Rivera-Iniguez I, Roman S. Dopamine D2 receptor polymorphism (C957T) is associated with sugar consumption and triglyceride levels in West Mexicans. Physiol Behav. 2018 Oct 1;194:532-537. doi: 10.1016/j.physbeh.2018.07.004. Epub 2018 Jul 4.
- Background: PubMed 17577539Yen JY, Ko CH, Yen CF, Wu HY, Yang MJ. The comorbid psychiatric symptoms of Internet addiction: attention deficit and hyperactivity disorder (ADHD), depression, social phobia, and hostility. J Adolesc Health. 2007 Jul;41(1):93-8. doi: 10.1016/j.jadohealth.2007.02.002. Epub 2007 Apr 12.
- Background: PubMed 30986731Del-Ponte B, Quinte GC, Cruz S, Grellert M, Santos IS. Dietary patterns and attention deficit/hyperactivity disorder (ADHD): A systematic review and meta-analysis. J Affect Disord. 2019 Jun 1;252:160-173. doi: 10.1016/j.jad.2019.04.061. Epub 2019 Apr 10.
- Background: PubMed 28807776Restrepo C, Manfredini D, Lobbezoo F. Sleep behaviors in children with different frequencies of parental-reported sleep bruxism. J Dent. 2017 Nov;66:83-90. doi: 10.1016/j.jdent.2017.08.005. Epub 2017 Aug 12.
- Background: PubMed 30529777Bach SL, Moreira FP, Goettems ML, Brancher LC, Oses JP, da Silva RA, Jansen K. Salivary cortisol levels and biological rhythm in schoolchildren with sleep bruxism. Sleep Med. 2019 Feb;54:48-52. doi: 10.1016/j.sleep.2018.09.031. Epub 2018 Oct 28.
- Individual participant dataSharing planned: No
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.
Claudia C Restrepo, PHD principal investigator
CES LPH research group
Ruben D Manrique, PHD study chair
CES LPH research group
Questions about this trial
What is this clinical trial studying?
A study testing Food, fun and family and Counseling in people with Sleep Bruxism, Childhood, run by CES 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 12 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 4 Apr 2022. 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 Claudia C Restrepo, PHD (5744440555 ext. 1550, crestrepos@ces.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frecuency of sleep bruxism (time frame: 8 weeks). 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 NCT05310162, which also lists 37 linked publications.
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 4 Apr 2022.