Mouth BreathingNCT01269957
Halitosis and Mouth Breathing in Children
An observational study of Mouth Breathing and Halitosis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Objective: determine whether there is a correlation between halitosis and mouth breathing in children. Study design: Fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing, Halitosis
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Aug 2010
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study. The children were divided into two groups based on breathing pattern (nasal and mouth) for the evaluation of halitosis. Breathing pattern was determined by a clinical evaluation and specific tests (mirror test and water-in-mouth test) and confirmed by the evaluation of an otolaryngologist.
Who may be able to join
- All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Objective: determine whether there is a correlation between halitosis and mouth breathing in children. Study design: Fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive analysis was carried out regarding the degree of halitosis in each group. The chi-square test was used for the comparison between groups, with 5% level of significance.
- Conditions
- Mouth Breathing, Halitosis
- Keywords
- halitosis, pediatric dentistry, mouth breathing
- Medical subject headings
- Mouth Breathing, Halitosis
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 |
|---|---|---|
| Mouth breathing | Not described | |
| Nasal breathing | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mouth BreathingStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Investigators
- Lara Motta, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269957
- Sponsor's protocol ID
- HMB029/2009
- Status last verified
- Aug 2010
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Motta LJ, Bachiega JC, Guedes CC, Laranja LT, Bussadori SK. Association between halitosis and mouth breathing in children. Clinics (Sao Paulo). 2011;66(6):939-42. doi: 10.1590/s1807-59322011000600003.
PubMed 21808855
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Halitosis and Mouth Breathing in Children
- ClinicalTrials.gov ID
- NCT01269957
- Acronym / sponsor ID
- HMB029/2009
- Conditions
- Mouth Breathing, Halitosis
- Keywords
- halitosis, pediatric dentistry, mouth breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Jan 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.
Objective: determine whether there is a correlation between halitosis and mouth breathing in children. Study design: Fifty-five children between three and 14 years of age were divided into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive analysis was carried out regarding the degree of halitosis in each group. The chi-square test was used for the comparison between groups, with 5% level of significance.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouth breathing | – | – |
| Nasal breathing | – | – |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study. The children were divided into two groups based on breathing pattern (nasal and mouth) for the evaluation of halitosis. Breathing pattern was determined by a clinical evaluation and specific tests (mirror test and water-in-mouth test) and confirmed by the evaluation of an otolaryngologist.
Key inclusion criteria (1 listed)
- All children registered at the clinic of the specialization course in pediatric dentistry of the ABCD/SP in 2008 were included in the study.
Key exclusion criteria (1 listed)
- -
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 4 Jan 2011.
- Derived from this study: PubMed 21808855Motta LJ, Bachiega JC, Guedes CC, Laranja LT, Bussadori SK. Association between halitosis and mouth breathing in children. Clinics (Sao Paulo). 2011;66(6):939-42. doi: 10.1590/s1807-59322011000600003.
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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 principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth Breathing and Halitosis, run by University of Nove de Julho 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 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 4 Jan 2011. 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?
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?
On the ClinicalTrials.gov record for NCT01269957, which also lists 1 linked publication.
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 Jan 2011.