MalocclusionNCT03846518
Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion
A study testing Hyrax and mini Hyrax in people with Malocclusion and Posterior Crossbite, run by Pontifícia Universidade Católica de Minas Gerais at 1 site in Brazil.
Trial summary
This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Malocclusion, Posterior Crossbite
- What is being tested?
- Hyrax and mini Hyrax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2018to 27 Feb 2020
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Maxillary permanent dentition, except canines
- Ages ranging from 12 to 16 years old;
- Maxillary constriction associated to posterior crossbite uni or bilateral.
Who cannot join
- Cleft lip and palate;
- Craniofacial syndromes;
- Carious lesions;
- History of previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica de Minas Gerais
Belo Horizonte, Minas Gerais, 30.535-901
About this study
Official title: Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.
Read the detailed description
Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe. A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. The sample size calculation indicated a total sample of 28 individuals. Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each. Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2). OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2). In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. After the normality test, the appropriate statistical test will be used in the intergroup comparison. A significance level of 5% will be regarded for all tests.
- Conditions
- Malocclusion, Posterior Crossbite
- Being tested
- Hyrax, mini Hyrax
- Keywords
- palatal expansion technique, adolescent, quality of life
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyraxDevice
Rapid maxillary expansion using the Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
mini HyraxDevice
Rapid maxillary expansion using the mini Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Hyrax group | Active comparator | Seventeen patients will be submitted to rapid maxillary expansion (RME) using the Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. Receives: Device: Hyrax |
| mini Hyrax group | Experimental | Seventeen patients will be submitted to rapid maxillary expansion (RME) using the mini Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. Receives: Device: mini Hyrax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary first molars width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary first molars
Measured: 6 months
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary first bicuspids
Measured: 6 months
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
Distance between centroid points of maxillary second bicuspids
Measured: 6 months
Maxillary first molas angulation. Scale in degrees and one decimal place.
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar.
Measured: 6 months
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
Measured: 6 months
Maxillary first molas inclination. Scale in degrees and one decimal place.
Angulation formed, in coronal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar
Measured: 6 months
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
Angulation formed, in coronal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
Measured: 6 months
Secondary outcomes (2)
Quality of life evaluation using questionnaires
Oral Health Impact Profile (OHIP-14) will be used to evaluate the quality of life of the patients before, during and after treatment. Fourteen items that explore seven dimensions of impact: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. The responses will be classified using the Likert scale with five options ranging from "never" (0) to "very often" (4). Higher values represent higher levels of impact on each dimension.
Measured: 2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
Discomfort evaluation using questionnaires
A Visual Analog Scale will be used from 0 to 100. Scale in millimeters and one decimal place. Higher values represent higher level of pain. The 0 point represents absence of pain and the 100 point represents the maximum pain that patient imagines is possible exist.
Measured: 24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Dec 2018
- Primary completion18 Sep 2019
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: control group (Hyrax) and experimental group (mini Hyrax)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica de Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Dauro Douglas Oliveira, Pontifícia Universidade Católica de Minas Gerais
- Investigators
- Dauro D Oliveira, PhD, Study chair, Associate professor and program director of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846518
- Sponsor's protocol ID
- hyraxversusminihyrax
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2019
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion: Dentoalveolar Effects and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT03846518
- Acronym / sponsor ID
- hyraxversusminihyrax
- Conditions
- Malocclusion, Posterior Crossbite
- Keywords
- palatal expansion technique, adolescent, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pontifícia Universidade Católica de Minas GeraisUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 19 Feb 2019 (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 dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.
Detailed description
Transverse maxilla deficiency is characterized by narrowing of the maxillary arch with important functional and esthetic impact. In individuals which have not reached bone maturity, a rapid expansion of the maxilla by using tooth-borne expanders as Haas and Hyrax appliance are efficient and safe. A presentation of favorable results for the "mini-Hyrax inverted" expander with a small screw in the transversal correction of the maxilla in patients with cleft lip and palate, besides improving the comfort and the teeth cleaning, provoked an idea of application of this small screw to correct posterior crossbite in individuals without cleft lip and palate. The objective of this study is to compare the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in adolescent patients with permanent dentition and active bone growth. The sample size calculation indicated a total sample of 28 individuals. Taking into account the loss of sample during the study, 34 subjects that have posterior crossbite and age from 12 to 16 years, will be recruited at the Dental School, Pontifical University Catholic of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. These patients will be randomly divided into two groups, Hyrax and mini Hyrax, with 17 patients each. Digital models of both dental arches will be obtained by intraoral scanning precede the procedure (T0) and at the end of the retention period, after appliance removal (T2). OHIP-14 Oral Health Impact Profile Questionnaires, validated in Portuguese, will be applied before expansion (T0), after an expansion (T1) and at the end of the retention period (T2). In digital dental models, maxillary first and second bicuspids and first molar width, and rotation and inclination of maxillary first bicuspids and first molars will be assessed. After the normality test, the appropriate statistical test will be used in the intergroup comparison. A significance level of 5% will be regarded for all tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups: control group (Hyrax) and experimental group (mini Hyrax)
| Arm | Type | Receives |
|---|---|---|
| Hyrax group | Active comparator | Device: HyraxSeventeen patients will be submitted to rapid maxillary expansion (RME) using the Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. |
| mini Hyrax group | Experimental | Device: mini HyraxSeventeen patients will be submitted to rapid maxillary expansion (RME) using the mini Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Maxillary permanent dentition, except canines
- Ages ranging from 12 to 16 years old;
- Maxillary constriction associated to posterior crossbite uni or bilateral.
Key exclusion criteria (4 listed)
- Cleft lip and palate;
- Craniofacial syndromes;
- Carious lesions;
- 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 |
|---|---|---|
| HyraxRapid maxillary expansion using the Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months. | Device | Hyrax group |
| mini HyraxRapid maxillary expansion using the mini Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months. | Device | mini Hyrax group |
Primary outcome
Maxillary first molars width. Scale in millimeters and one decimal place.
Time frame: 6 months
Distance between centroid points of maxillary first molars
Maxillary first bicuspid width. Scale in millimeters and one decimal place.
Time frame: 6 months
Distance between centroid points of maxillary first bicuspids
Maxillary second bicuspid width. Scale in millimeters and one decimal place.
Time frame: 6 months
Distance between centroid points of maxillary second bicuspids
Maxillary first molas angulation. Scale in degrees and one decimal place.
Time frame: 6 months
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar.
Maxillary first bicuspids angulation. Scale in degrees and one decimal place.
Time frame: 6 months
Angulation formed, in occlusal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
Maxillary first molas inclination. Scale in degrees and one decimal place.
Time frame: 6 months
Angulation formed, in coronal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar
Maxillary first bicuspids inclination. Scale in degrees and one decimal place.
Time frame: 6 months
Angulation formed, in coronal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid
2 secondary outcomes
Quality of life evaluation using questionnaires
Time frame: 2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)
Discomfort evaluation using questionnaires
Time frame: 24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)
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 5 Mar 2020.
- 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.
Dauro D Oliveira, PhD study chair
Associate professor and program director of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyrax and mini Hyrax in people with Malocclusion and Posterior Crossbite, run by Pontifícia Universidade Católica de Minas Gerais 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 3 inclusion and 4 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 5 Mar 2020. 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 first molars width. Scale in millimeters and one decimal place. (time frame: 6 months). The study lists 7 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 5 Mar 2020.