Maxillary ConstrictionNCT02810353
Analysis of the Dentoskeletal Effects of the Expander With Differential Opening
A study testing Differential rapid maxillary expansion and Conventional rapid maxillary expansion in people with Maxillary Constriction and Unilateral Posterior Crossbite, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Maxillary Constriction, Unilateral Posterior Crossbite, Bilateral Posterior Crossbite
- What is being tested?
- Differential rapid maxillary expansion and Conventional rapid maxillary expansion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Feb 2018
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sexes;
- Ages ranging from 7 to 11 years old;
- Mixed dentition;
- Maxillary constriction;
- No previous orthodontic treatment.
Who cannot join
- Cleft lip and palate and associated syndromes;
- Systemic and/or neurological diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
Bauru, São Paulo, 17012059
Arthur Alves, DDS, MSc, +55 14 981060878, arthurcesar_88@hotmail.com
About this study
Official title: Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.
Read the detailed description
Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p<0.05).
- Conditions
- Maxillary Constriction, Unilateral Posterior Crossbite, Bilateral Posterior Crossbite, Mandibular Dental Arch Constriction
- Being tested
- Differential rapid maxillary expansion, Conventional rapid maxillary expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential rapid maxillary expansionDevice
Also called RME with the expander with differential opening
Twenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.
Conventional rapid maxillary expansionDevice
Also called RME with the conventional Hyrax expander
Twenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Expander with differential opening group | Experimental | The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion using the expander with differential opening. The expander will be composed by two 11-mm screws, one anteriorly and the other posteriorly positioned on the palate (Great lakes Orthodontics Ltd, NY, EUA). Receives: Device: Differential rapid maxillary expansion |
| Hyrax group | Active comparator | The control group will be comprised by 25 patients who will undergo rapid maxillary expansion using the conventional Hyrax expander. The expander will be composed by one 11-mm screw centrally positioned on the palate (Dentaurum, Ispringen, Germany). Receives: Device: Conventional rapid maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary and mandibular inter-first permanent molar distances
Measured: 6 months
Maxillary and mandibular inter-second deciduous molar distances
Measured: 6 months
Maxillary and mandibular inter-first deciduous molar distances
Measured: 6 months
Maxillary and mandibular inter-deciduous canine distances
Measured: 6 months
Maxillary and mandibular dental arches perimeters
Measured: 6 months
Maxillary and mandibular dental arches lengths
Measured: 6 months
Palatal depth
Measured: 6 months
Inclination of maxillary and mandibular first permanent molars
Measured: 6 months
Inclination of maxillary and mandibular deciduous canines
Measured: 6 months
Amount of interincisor diastema
Measured: 10 days
Secondary outcomes (1)
Amount of differential expansion on the maxillary and mandibular dental arches
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary ConstrictionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur César de Medeiros Alves, University of Sao Paulo
- Investigators
- Arthur Alves, DDS, MSc, Principal investigator, Bauru Dental School, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810353
- Sponsor's protocol ID
- Bauru Dental School, USP
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02810353
- Acronym / sponsor ID
- Bauru Dental School, USP
- Conditions
- Maxillary Constriction, Unilateral Posterior Crossbite, Bilateral Posterior Crossbite, Mandibular Dental Arch Constriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 22 Jun 2016 (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.
This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.
Detailed description
Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expander with differential opening group | Experimental | Device: Differential rapid maxillary expansionThe experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion using the expander with differential opening. The expander will be composed by two 11-mm screws, one anteriorly and the other posteriorly positioned on the palate (Great lakes Orthodontics Ltd, NY, EUA). |
| Hyrax group | Active comparator | Device: Conventional rapid maxillary expansionThe control group will be comprised by 25 patients who will undergo rapid maxillary expansion using the conventional Hyrax expander. The expander will be composed by one 11-mm screw centrally positioned on the palate (Dentaurum, Ispringen, Germany). |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both sexes;
- Ages ranging from 7 to 11 years old;
- Mixed dentition;
- Maxillary constriction;
- No previous orthodontic treatment.
Key exclusion criteria (2 listed)
- Cleft lip and palate and associated syndromes;
- Systemic and/or neurological 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 |
|---|---|---|
| Differential rapid maxillary expansionAlso: RME with the expander with differential openingTwenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months. | Device | Expander with differential opening group |
| Conventional rapid maxillary expansionAlso: RME with the conventional Hyrax expanderTwenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months. | Device | Hyrax group |
Primary outcome
Maxillary and mandibular inter-first permanent molar distances
Time frame: 6 months
Maxillary and mandibular inter-second deciduous molar distances
Time frame: 6 months
Maxillary and mandibular inter-first deciduous molar distances
Time frame: 6 months
Maxillary and mandibular inter-deciduous canine distances
Time frame: 6 months
Maxillary and mandibular dental arches perimeters
Time frame: 6 months
Maxillary and mandibular dental arches lengths
Time frame: 6 months
Palatal depth
Time frame: 6 months
Inclination of maxillary and mandibular first permanent molars
Time frame: 6 months
Inclination of maxillary and mandibular deciduous canines
Time frame: 6 months
Amount of interincisor diastema
Time frame: 10 days
1 secondary outcome
Amount of differential expansion on the maxillary and mandibular dental arches
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Maxillary Constriction
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Orofacial Muscle Pressure and Maxillary Transverse Development
Maxillary Transversal Deficiency (Maxillary Constriction) and Perioral Muscle Pressures (Tongue, Lip, and Cheek)
Active, not recruiting
Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial
Maxillary Expansion in Cleft Lip and Palate Patients, Dentoskeletal Effects After Expansion Using Two Different Expanders
Enrolling by invitation
Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction
Apnea, Obstructive Sleep
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.
Arthur Alves, DDS, MSc principal investigator
Bauru Dental School, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differential rapid maxillary expansion and Conventional rapid maxillary expansion in people with Maxillary Constriction and Unilateral Posterior Crossbite, run by University of Sao Paulo 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 5 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 22 Jun 2016. 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 Arthur Alves, DDS, MSc (+55 14 981060878, arthurcesar_88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary and mandibular inter-first permanent molar distances (time frame: 6 months). The study lists 10 primary outcomes in all. 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 22 Jun 2016.