Maxillary Transverse Deficiency (MTD)NCT04760535
Effectiveness of Aligners Versus Rapid Maxillary Expansion
A study testing Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA) and Tooth-borne Hyrax-type maxillary expander in people with Maxillary Transverse Deficiency (MTD), run by University of Turin, Italy at 1 site in Italy.
Trial summary
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Maxillary Transverse Deficiency (MTD)
- What is being tested?
- Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA) and Tooth-borne Hyrax-type maxillary expander
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2019to 3 May 2021
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who have been diagnosed with transverse maxillary deficiency;
- mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
- fully erupted upper and lower first molars;
- transversal discrepancy ≤5mm
- demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
- subjects willing to consent to the trial and comply with the trial regime.
Who cannot join
- any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
- permanent teeth extraction-based treatment (third molars excluded);
- morphologic crown anomalies;
- auxiliary treatment during arch expansion stage (such as crossbite elastics);
- posterior interproximal reduction;
- orthognathic surgery treatment planned;
- cleft palate or severe facial deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Aligners Versus Rapid Maxillary Expansion on 3D Palatal Volume in Mixed Dentition Patients: a Randomized Controlled Trial
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.
Read the detailed description
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. This two-arm parallel-group randomized prospective clinical trial will include patients with: indications for maxillary expansion treatment, age between 6 and 10 years old, mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed by the practitioner. Patients will be assigned to one of two expansion methods (arm A: Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according to a computer-generated randomization list shortly before the start of expansion Primary outcome measure will be the change in palatal morphology (palatal volume and surface area variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper inter-molar width, anterior segment length, posterior segment length), complications, patients' satisfaction and periodontal health. Due to the nature of the intervention blinding will not be possible. Potential statistical differences between the two intervention groups will be evaluated.
- Conditions
- Maxillary Transverse Deficiency (MTD)
- Being tested
- Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA), Tooth-borne Hyrax-type maxillary expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)Device
Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.
Tooth-borne Hyrax-type maxillary expanderDevice
The expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Invisalign® First clear aligners | Experimental | The Invisalign® First aligners are fabricated in a multilayer aromatic thermoplastic polyurethane/co-polyester 0.75mm (.030")-thick with a fine 3D manufacturing process. Receives: Device: Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA) |
| Arm B: tooth-borne Hyrax-type maxillary expander | Active comparator | The Hyrax-type maxillary expander is a tooth-borne expansion appliance that is fixed to the upper second deciduous molars (or to the first permanent molars) using bands and includes a midline 12-mm self-locking screw (Forestadent, Pforzheim, Germany; 0.9 mm, complete turn). The expansion screw is connected to the conventional molar bands or printed clasps, modeled surrounding the molars, via a framework of 0.9mm stainless-steel wire. The framework is soldered to the bands and extending on the palatal side to the deciduous canines. The expander will be fabricated by qualified laboratory technician. Receives: Device: Tooth-borne Hyrax-type maxillary expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palate morphology
The primary outcome will be to evaluate the changes in palatal morphology after the treatment of maxillary deficiencies using two different therapies and to re-evaluate changes over the initial 12-months after the end of the treatment. The changes in palatal morphology are defined as the variation in palatal volume and surface. These will be measured from digitized study models within the boundaries of the palate, the gingival and distal planes, defined as follow. The gingival plane will be created by connecting the midpoints of the dentogingival junction of all upper erupted deciduous and permanent teeth. The distal plane will be created through two points at the distal of the first upper permanent molars perpendicular to the gingival plane.
Measured: 12 months
Secondary outcomes (2)
Upper inter-canine width (ICW)
Upper inter-canine width (ICW) (secondary outcome measure) is the transverse distance between upper canines in millimeters.
Measured: 12 months
Upper inter-molar width (IMW)
Upper inter-molar width (IMW) (secondary outcome measure) is the transverse distance between upper first molars in millimeters.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Jan 2019
- Primary completion15 Oct 2020
- Study completion3 May 2021
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 Maxillary Transverse Deficiency (MTD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Castroflorio, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760535
- Sponsor's protocol ID
- Maxillary Expansion
- Status last verified
- May 2022
- First submitted
- 14 Feb 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruni A, Ferrillo M, Gallo V, Parrini S, Garino F, Castroflorio T, Deregibus A. Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):203-214. doi: 10.1016/j.ajodo.2024.04.006. Epub 2024 Jul 26.
PubMed 39066746
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aligners Versus Rapid Maxillary Expansion on 3D Palatal Volume in Mixed Dentition Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04760535
- Acronym / sponsor ID
- Maxillary Expansion
- Conditions
- Maxillary Transverse Deficiency (MTD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 18 Feb 2021 (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.
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.
Detailed description
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. This two-arm parallel-group randomized prospective clinical trial will include patients with: indications for maxillary expansion treatment, age between 6 and 10 years old, mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed by the practitioner. Patients will be assigned to one of two expansion methods (arm A: Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according to a computer-generated randomization list shortly before the start of expansion Primary outcome measure will be the change in palatal morphology (palatal volume and surface area variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper inter-molar width, anterior segment length, posterior segment length), complications, patients' satisfaction and periodontal health. Due to the nature of the intervention blinding will not be possible. Potential statistical differences between the two intervention groups will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Invisalign® First clear aligners | Experimental | Device: Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)The Invisalign® First aligners are fabricated in a multilayer aromatic thermoplastic polyurethane/co-polyester 0.75mm (.030")-thick with a fine 3D manufacturing process. |
| Arm B: tooth-borne Hyrax-type maxillary expander | Active comparator | Device: Tooth-borne Hyrax-type maxillary expanderThe Hyrax-type maxillary expander is a tooth-borne expansion appliance that is fixed to the upper second deciduous molars (or to the first permanent molars) using bands and includes a midline 12-mm self-locking screw (Forestadent, Pforzheim, Germany; 0.9 mm, complete turn). The expansion screw is connected to the conventional molar bands or printed clasps, modeled surrounding the molars, via a framework of 0.9mm stainless-steel wire. The framework is soldered to the bands and extending on the palatal side to the deciduous canines. The expander will be fabricated by qualified laboratory technician. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- patients who have been diagnosed with transverse maxillary deficiency;
- mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
- fully erupted upper and lower first molars;
- transversal discrepancy ≤5mm
- demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
Key exclusion criteria (7 listed)
- any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
- permanent teeth extraction-based treatment (third molars excluded);
- morphologic crown anomalies;
- auxiliary treatment during arch expansion stage (such as crossbite elastics);
- posterior interproximal reduction;
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 |
|---|---|---|
| Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents. | Device | Arm A: Invisalign® First clear aligners |
| Tooth-borne Hyrax-type maxillary expanderThe expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents. | Device | Arm B: tooth-borne Hyrax-type maxillary expander |
Primary outcome
Palate morphology
Time frame: 12 months
The primary outcome will be to evaluate the changes in palatal morphology after the treatment of maxillary deficiencies using two different therapies and to re-evaluate changes over the initial 12-months after the end of the treatment. The changes in palatal morphology are defined as the variation in palatal volume and surface. These will be measured from digitized study models within the boundaries of the palate, the gingival and distal planes, defined as follow. The gingival plane will be created by connecting the midpoints of the dentogingival junction of all upper erupted deciduous and permanent teeth. The distal plane will be created through two points at the distal of the first upper permanent molars perpendicular to the gingival plane.
2 secondary outcomes
Upper inter-canine width (ICW)
Time frame: 12 months
Upper inter-molar width (IMW)
Time frame: 12 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 25 May 2022.
- Derived from this study: PubMed 39066746Bruni A, Ferrillo M, Gallo V, Parrini S, Garino F, Castroflorio T, Deregibus A. Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):203-214. doi: 10.1016/j.ajodo.2024.04.006. Epub 2024 Jul 26.
- Individual participant dataSharing planned: No
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 Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA) and Tooth-borne Hyrax-type maxillary expander in people with Maxillary Transverse Deficiency (MTD), run by University of Turin, Italy at 1 site in Italy.
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 6 inclusion and 7 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 25 May 2022. 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 Italy. 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?
Palate morphology (time frame: 12 months). 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 NCT04760535, 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 25 May 2022.