Sleep Bruxism, ChildhoodNCT04501237
Sleep Hygiene Measures for Sleep Bruxism in Children
A study testing Bruxers with sleep hygiene instructions in people with Sleep Bruxism, Childhood, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Childhood
- What is being tested?
- Bruxers with sleep hygiene instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2020to 1 May 2021
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with probable sleep bruxism
Who cannot join
- systemic diseases;
- Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
School of dentistry
Pelotas, Rio Grande do Sul, 96015560
MArilia L Goettems, PhD, 555332256741, mariliagoettems@gmail.com
About this study
Official title: Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children
The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. In randomization both groups will receive information about bruxism, and the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will be assessed through a diary to be completed by the child's responsible party. A randomized, stratified sample of approximately 16 children will be included in the study. One group will be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene intervention, and another group of children who will only receive instructions on sleep bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger / thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental smoking, problems breathing, parental profession and also on psychological issues. Sleep habits will also be answered in this questionnaire, and parents will also answer the Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child Stress Scale and the Child of stressing sources in child; children less than 6 years will have the questionnaire responded by parents. The children will undergo a clinical examination to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The study evaluations consist of baseline, 1, 7, 15 and 30 days.
- Conditions
- Sleep Bruxism, Childhood
- Being tested
- Bruxers with sleep hygiene instructions
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxers with sleep hygiene instructionsBehavioural
the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.
| Study group | Role | What they receive |
|---|---|---|
| Bruxers without sleep hygiene instructions | No intervention | Not described |
| Bruxers with sleep hygiene instructions | Experimental | Not described Receives: Behavioral: Bruxers with sleep hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Strengths and Difficulties Questionnaire
Measured: Responded 1 month after intervention in both groups
Secondary outcomes (1)
Clinical evaluation of child teeth
Basic Erosive Wear Examination Index
Measured: Analyzed 1 month after intervention in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501237
- Sponsor's protocol ID
- PPGO 032
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sleep Hygiene Measures in the Occurrence of Sleep Bruxism in Children
- ClinicalTrials.gov ID
- NCT04501237
- Acronym / sponsor ID
- PPGO 032
- Conditions
- Sleep Bruxism, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 6 Aug 2020 (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.
The aim of the study is to evaluate the efficacy of sleep hygiene measures for the possible improvement of sleep bruxism in children through a randomized controlled clinical study of children under 8 years of age with probable sleep bruxism. In randomization both groups will receive information about bruxism, and the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. The occurrence of sleep bruxism will be assessed through a diary to be completed by the child's responsible party. A randomized, stratified sample of approximately 16 children will be included in the study. One group will be composed of 8 children with probable sleep bruxism who will receive the sleep hygiene intervention, and another group of children who will only receive instructions on sleep bruxism, with causes and consequences. Participants will be followed-up for 30 days. Parents will respond to a questionnaire about socioeconomic, demographic (child's age and gender), as well as parafunctional habits such as nail biting, biting objects, pacifier sucking, finger / thumb sucking and bottle feeding, child's sleep characteristics, screen habits, parental smoking, problems breathing, parental profession and also on psychological issues. Sleep habits will also be answered in this questionnaire, and parents will also answer the Strengths and Difficulties Questionnaire. The children over 6 years old will respond a Child Stress Scale and the Child of stressing sources in child; children less than 6 years will have the questionnaire responded by parents. The children will undergo a clinical examination to assess dental wear, according to the BEWE (Basic Erosive Wear Examination Index). The study evaluations consist of baseline, 1, 7, 15 and 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxers without sleep hygiene instructions | No intervention | – |
| Bruxers with sleep hygiene instructions | Experimental | Behavioral: Bruxers with sleep hygiene instructions |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with probable sleep bruxism
Key exclusion criteria (2 listed)
- systemic diseases;
- Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child.
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 |
|---|---|---|
| Bruxers with sleep hygiene instructionsthe test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio. | Behavioural | Bruxers with sleep hygiene instructions |
Primary outcome
Questionnaire
Time frame: Responded 1 month after intervention in both groups
Strengths and Difficulties Questionnaire
1 secondary outcome
Clinical evaluation of child teeth
Time frame: Analyzed 1 month after intervention in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bruxers with sleep hygiene instructions in people with Sleep Bruxism, Childhood, run by Federal University of Pelotas at 1 site in Brazil.
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 1 inclusion and 2 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 6 Aug 2020. 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 Brazil. 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 Marilia L Goettems, PhD (555332256741, mariliagoettems@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: Responded 1 month after intervention in both groups). 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 6 Aug 2020.