MalocclusionNCT03705871
Dentoskeletal Effects of the Expander With Differential Opening and the Fan-type Expander
A study testing Differential Expansion and Fan-Fype Expander in people with Malocclusion and Crossbite (Posterior), run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Malocclusion, Crossbite (Posterior)
- What is being tested?
- Differential Expansion and Fan-Fype Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Nov 2017to 1 Feb 2019
- 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;
- Mixed dentition;
- Ages ranging from 7 to 11 years old;
- Maxillary constriction associated to posterior crossbites;
- Angle Class I or Angle Class II malocclusions.
Who cannot join
- Cleft lip and palate;
- Craniofacial syndromes;
- Carious lesions;
- Angle Class III malocclusion;
- History of previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Bauru Dental School - University of São Paulo
Bauru, São Paulo, 17012-901
About this study
Official title: Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial
This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.
Read the detailed description
Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary constriction and posterior crossbite, and the study of dental, skeletal and periodontal effects of this procedure has been widely discussed in the orthodontic literature. The conventional RME expanders promote a similar expansion in the anterior and posterior regions of the maxillary arch. On the other hand, the fan-type expander allows the expansion concentrated in the intercanine region with little effects the intermolar distance. Finally, the expander with differential opening has two palatal screws and the differential activation protocol promotes a different amount of expansion for the anterior and posterior regions of the maxilla. No clinical study compared dental and skeletal effects of the expander with differential opening with those of the fan-type expander, including a three-dimensional analysis using CBCT exams and digital dental models. So, the aim of the present randomized clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander with differential opening and the fan-type expander in the mixed dentition.
For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with transverse maxillary dental arch constriction will be prospectively and randomly allocated into two study groups. The first group will consist of 24 individuals treated with the expander with differential opening (DEG). The second group will consist of 24 individuals treated with the fan-type expander (FEG). In 12 patients from each group (immediate subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24 patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6 months after maxillary expansion (T3). Dental models will be obtained for all patients at T1 and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The opening of the midpalatal suture at the anterior and posterior region and the geometry of the suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and quality of life will be evaluated by questionnaires.
After the normality test, the paired t test will be used in the intragroup comparison, and the independent t test will be used in the intergroup comparison. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests.
Possible harms that could appear are related to temporary discomfort during the first days after the installation of the expander. Patients and legal guardians will be carefully oriented and they will be able to stop the treatment at any moment.
- Conditions
- Malocclusion, Crossbite (Posterior)
- Being tested
- Differential Expansion, Fan-Fype Expander
- Keywords
- Palatal Expansion Technique, Cone-Beam Computed Tomography, Dental Models
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential ExpansionDevice
Twenty-four patients will be treated with a rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm in the anterior screw of the expander. 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.
Fan-Fype ExpanderDevice
Twenty-four patients will be treated with a rapid maxillary expansion using the fan-type expander. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm screw of the expander. 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.
| Study group | Role | What they receive |
|---|---|---|
| Differential Expansion Group | Experimental | The experimental group will be comprised 24 patients treated with a rapid maxillary expansion using the expander with differential opening. The expander is composed by two screws, one posteriorly and the other anteriorly positioned on the palate. Receives: Device: Differential Expansion |
| Fan-Fype Expander Group | Active comparator | The active comparator group will be comprised by 24 patients treated with rapid maxillary expansion using the the fan-type expander. The expander is composed by one screw anteriorly positioned on the palate. Receives: Device: Fan-Fype Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary and mandibular arch width (mm)
Measurements will be performed in digital dental models
Measured: 6 months
Maxillary and mandibular arch length
Measurements will be performed in digital dental models
Measured: 6 months
Maxillary and mandibular arch perimeter (mm)
Measurements will be performed in digital dental models
Measured: 6 months
Nasal cavity width (mm)
Measurements will be performed in coronal sections of CBCT exams.
Measured: 6 months
Maxillary width (mm)
Measurements will be performed in coronal sections of CBCT exams.
Measured: 6 months
Maxillary molars inclination (°)
Measurement will be performed in CBCT scans.
Measured: 6 months
Maxillary deciduous canines inclination (°)
Measurement be performed CBCT scans.
Measured: 6 months
Amount of interincisor diastema (mm)
Measurement will be assessed in CBCT scans.
Measured: 10 days
Opening of the midpalatal suture (mm)
Measurement be assessed in axial and coronal sections of CBCT scans.
Measured: 10 days
Secondary outcomes (3)
Discomfort evaluation using questionnaires
A Visual Analog Scale will be used from 0 to 10 cm.
Measured: 1 month
Quality of life evaluation using questionnaires
The Child Perceptions Questionnaire (CPQ8-10) will be used to evaluate the quality of life of the patients before and after treatment.
Measured: 6 months
Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.
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 posted15 Oct 2018
- Study start8 Nov 2017
- Primary completion15 Dec 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Camila Massaro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705871
- Sponsor's protocol ID
- 71648917.6.0000.5417
- Status last verified
- Apr 2019
- First submitted
- 7 Oct 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teixeira R, Massaro C, Garib D. Vertical and sagittal changes produced by an expander with differential opening versus a fan-type expander: A post-hoc analysis of a randomised controlled trial. J Orthod. 2024 Dec;51(4):388-396. doi: 10.1177/14653125231208465. Epub 2023 Oct 31.
PubMed 37905906Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
PubMed 33580351Massaro C, Janson G, Miranda F, Aliaga-Del Castillo A, Pugliese F, Lauris JRP, Garib D. Dental arch changes comparison between expander with differential opening and fan-type expander: a randomized controlled trial. Eur J Orthod. 2021 Jun 8;43(3):265-273. doi: 10.1093/ejo/cjaa050.
PubMed 32840319
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03705871
- Acronym / sponsor ID
- 71648917.6.0000.5417
- Conditions
- Malocclusion, Crossbite (Posterior)
- Keywords
- Palatal Expansion Technique, Cone-Beam Computed Tomography, Dental Models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 Oct 2018 (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.
This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.
Detailed description
Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary constriction and posterior crossbite, and the study of dental, skeletal and periodontal effects of this procedure has been widely discussed in the orthodontic literature. The conventional RME expanders promote a similar expansion in the anterior and posterior regions of the maxillary arch. On the other hand, the fan-type expander allows the expansion concentrated in the intercanine region with little effects the intermolar distance. Finally, the expander with differential opening has two palatal screws and the differential activation protocol promotes a different amount of expansion for the anterior and posterior regions of the maxilla. No clinical study compared dental and skeletal effects of the expander with differential opening with those of the fan-type expander, including a three-dimensional analysis using CBCT exams and digital dental models. So, the aim of the present randomized clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander with differential opening and the fan-type expander in the mixed dentition.
For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with transverse maxillary dental arch constriction will be prospectively and randomly allocated into two study groups. The first group will consist of 24 individuals treated with the expander with differential opening (DEG). The second group will consist of 24 individuals treated with the fan-type expander (FEG). In 12 patients from each group (immediate subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24 patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6 months after maxillary expansion (T3). Dental models will be obtained for all patients at T1 and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The opening of the midpalatal suture at the anterior and posterior region and the geometry of the suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and quality of life will be evaluated by questionnaires.
After the normality test, the paired t test will be used in the intragroup comparison, and the independent t test will be used in the intergroup comparison. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests.
Possible harms that could appear are related to temporary discomfort during the first days after the installation of the expander. Patients and legal guardians will be carefully oriented and they will be able to stop the treatment at any moment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Differential Expansion Group | Experimental | Device: Differential ExpansionThe experimental group will be comprised 24 patients treated with a rapid maxillary expansion using the expander with differential opening. The expander is composed by two screws, one posteriorly and the other anteriorly positioned on the palate. |
| Fan-Fype Expander Group | Active comparator | Device: Fan-Fype ExpanderThe active comparator group will be comprised by 24 patients treated with rapid maxillary expansion using the the fan-type expander. The expander is composed by one screw anteriorly positioned on the palate. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both sexes;
- Mixed dentition;
- Ages ranging from 7 to 11 years old;
- Maxillary constriction associated to posterior crossbites;
- Angle Class I or Angle Class II malocclusions.
Key exclusion criteria (5 listed)
- Cleft lip and palate;
- Craniofacial syndromes;
- Carious lesions;
- Angle Class III malocclusion;
- History of previous orthodontic treatment.
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 ExpansionTwenty-four patients will be treated with a rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm in the anterior screw of the expander. 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 | Differential Expansion Group |
| Fan-Fype ExpanderTwenty-four patients will be treated with a rapid maxillary expansion using the fan-type expander. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm screw of the expander. 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 | Fan-Fype Expander Group |
Primary outcome
Maxillary and mandibular arch width (mm)
Time frame: 6 months
Measurements will be performed in digital dental models
Maxillary and mandibular arch length
Time frame: 6 months
Measurements will be performed in digital dental models
Maxillary and mandibular arch perimeter (mm)
Time frame: 6 months
Measurements will be performed in digital dental models
Nasal cavity width (mm)
Time frame: 6 months
Measurements will be performed in coronal sections of CBCT exams.
Maxillary width (mm)
Time frame: 6 months
Measurements will be performed in coronal sections of CBCT exams.
Maxillary molars inclination (°)
Time frame: 6 months
Measurement will be performed in CBCT scans.
Maxillary deciduous canines inclination (°)
Time frame: 6 months
Measurement be performed CBCT scans.
Amount of interincisor diastema (mm)
Time frame: 10 days
Measurement will be assessed in CBCT scans.
Opening of the midpalatal suture (mm)
Time frame: 10 days
Measurement be assessed in axial and coronal sections of CBCT scans.
3 secondary outcomes
Discomfort evaluation using questionnaires
Time frame: 1 month
Quality of life evaluation using questionnaires
Time frame: 6 months
Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.
Time frame: 6 months
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 18 Apr 2019.
- Derived from this study: PubMed 37905906Teixeira R, Massaro C, Garib D. Vertical and sagittal changes produced by an expander with differential opening versus a fan-type expander: A post-hoc analysis of a randomised controlled trial. J Orthod. 2024 Dec;51(4):388-396. doi: 10.1177/14653125231208465. Epub 2023 Oct 31.
- Derived from this study: PubMed 33580351Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
- Derived from this study: PubMed 32840319Massaro C, Janson G, Miranda F, Aliaga-Del Castillo A, Pugliese F, Lauris JRP, Garib D. Dental arch changes comparison between expander with differential opening and fan-type expander: a randomized controlled trial. Eur J Orthod. 2021 Jun 8;43(3):265-273. doi: 10.1093/ejo/cjaa050.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Expansion and Fan-Fype Expander in people with Malocclusion and Crossbite (Posterior), 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 5 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 18 Apr 2019. 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?
Maxillary and mandibular arch width (mm) (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705871, which also lists 3 linked publications.
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 18 Apr 2019.