Cross-biteERMNCT01765062
One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children
An observational study of Cross-bite, run by State University of Maringá at 1 site in Brazil.
Trial summary
Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cross-bite
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Jul 2009
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Community Sample
Who may be able to join
- cross-bite with maxillary atresia
Who cannot join
- patients had undergone orthodontic treatment or had a syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.
- Conditions
- Cross-bite
- Keywords
- Rapid maxillary expansion, Cross bite, Haas appliance, Lateral cephalograms
- Medical subject headings
- Malocclusion
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 |
|---|---|---|
| Before Rapid Maxillary Expansion | T0 | |
| 3 months After Rapid Maxillary Expansion | T1 | |
| One year After Rapid Maxillary Expansion | T2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cephalometric variables
Measured: prior to rapid maxillary expansion (T0), after three months (T1) and after one year
Secondary outcomes (1)
Dental casts
Measured: prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross-biteStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Maringá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Barbisan de Souza, DDS, State University of Maringá
- Investigators
- Daniela G Garib, PHD, Principal investigator, Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765062
- Sponsor's protocol ID
- KRM-300585
- Acronym
- ERM
- Status last verified
- Jan 2013
- First submitted
- 20 Dec 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children
- ClinicalTrials.gov ID
- NCT01765062
- Acronym / sponsor ID
- ERM / KRM-300585
- Conditions
- Cross-bite
- Keywords
- Rapid maxillary expansion, Cross bite, Haas appliance, Lateral cephalograms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- State University of MaringáUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Jan 2013 (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.
Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before Rapid Maxillary Expansion | – | –T0 |
| 3 months After Rapid Maxillary Expansion | – | –T1 |
| One year After Rapid Maxillary Expansion | – | –T2 |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Community Sample
Key inclusion criteria (1 listed)
- cross-bite with maxillary atresia
Key exclusion criteria (1 listed)
- patients had undergone orthodontic treatment or had a syndrome
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
changes in cephalometric variables
Time frame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year
1 secondary outcome
Dental casts
Time frame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year (T2).
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 10 Jan 2013.
Related trials for Cross-bite
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Evaluation of Myobrace for Crossbite Correction in Mixed Dentition
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
Active, not recruitingObservational study
Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
Edentulism, Edentulism Complete
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.
Daniela G Garib, PHD principal investigator
Universidade de São Paulo-USP-Faculdade de Odontologia de Bauru
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 Cross-bite, run by State University of Maringá 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 10 Jan 2013. 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.
What does the primary outcome measure?
changes in cephalometric variables (time frame: prior to rapid maxillary expansion (T0), after three months (T1) and after one year). 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 10 Jan 2013.