BruxismRPCBNCT01463826
Respiratory Problems and Caries in Children With Bruxism
An observational study of Bruxism and Dental Caries, run by University of Nove de Julho.
Trial summary
The aim of the present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Dental Caries
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child
Study population: Children with either the complete primary or mixed dentition who were not in dental treatment were included in the study and divided into two groups: those with bruxism and those without bruxism. For the diagnosis of bruxism, a questionnaire was administered to determine the occurrence of teeth clenching/grinding and a physical exam was performed for the determination of dental wear based on the criteria of the American Academy of Sleep Medicine. Dental caries were determined based on the criteria of the World Health Organization
Who may be able to join
- Children with either the complete primary or mixed dentition who were not in dental treatment
Who cannot join
- Children in dental treatment
About this study
Official title: Association Between Respiratory Problem and Dental Caries in Children With Bruxism
The aim of the present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.
Read the detailed description
Objectives: The aim of the present study was to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.
Method: Patient histories were taken and clinical exams were performed on 90 children for selection and allocation to one of two groups. For the determination of bruxism, a questionnaire was administered to parents/guardians and an oral clinical exam was performed based on the criteria of the American Academy of Sleep Medicine. Thirty-three male and female children between four and seven years of age participated in the present study - 14 children with bruxism and 19 children without bruxism. The data were statistically analyzed using the chi-square test, with level of significance set at 5% (p < 0.05).
- Conditions
- Bruxism, Dental Caries
- Keywords
- bruxism, children, oral breathing, dental caries
- Medical subject headings
- Bruxism, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with bruxism | 14 children with bruxism | |
| children without bruxism | 19 children without bruxism |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
- Investigators
- Lara Motta, PhD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463826
- Sponsor's protocol ID
- br82622/08
- Acronym
- RPCB
- Status last verified
- Oct 2011
- First submitted
- 28 Oct 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Respiratory Problem and Dental Caries in Children With Bruxism
- ClinicalTrials.gov ID
- NCT01463826
- Acronym / sponsor ID
- RPCB / br82622/08
- Conditions
- Bruxism, Dental Caries
- Keywords
- bruxism, children, oral breathing, dental caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Nov 2011 (estimated)
- 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 present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.
Detailed description
Objectives: The aim of the present study was to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.
Method: Patient histories were taken and clinical exams were performed on 90 children for selection and allocation to one of two groups. For the determination of bruxism, a questionnaire was administered to parents/guardians and an oral clinical exam was performed based on the criteria of the American Academy of Sleep Medicine. Thirty-three male and female children between four and seven years of age participated in the present study - 14 children with bruxism and 19 children without bruxism. The data were statistically analyzed using the chi-square test, with level of significance set at 5% (p < 0.05).
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with bruxism | – | –14 children with bruxism |
| children without bruxism | – | –19 children without bruxism |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with either the complete primary or mixed dentition who were not in dental treatment were included in the study and divided into two groups: those with bruxism and those without bruxism. For the diagnosis of bruxism, a questionnaire was administered to determine the occurrence of teeth clenching/grinding and a physical exam was performed for the determination of dental wear based on the criteria of the American Academy of Sleep Medicine. Dental caries were determined based on the criteria of the World Health Organization
Key inclusion criteria (1 listed)
- Children with either the complete primary or mixed dentition who were not in dental treatment
Key exclusion criteria (1 listed)
- Children in dental treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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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.
Lara Motta, PhD principal investigator
Nove de Julho University
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism and Dental Caries, run by University of Nove de Julho.
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 1 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: finished, as of the sponsor's last update on 2 Nov 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 2 Nov 2011.