Maxillary Transverse DeficiencyNCT07262892
3D Evaluation of Maxillary Expansion Methods
A study testing Invisalign Palatal Expander (IPE) and Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance in people with Maxillary Transverse Deficiency, run by Büşra Zeynep Yörük at 1 site in Turkey (Türkiye).
Trial summary
This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- Invisalign Palatal Expander (IPE) and Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years
- Good oral hygiene and adequate patient cooperation
- No previous orthodontic expansion treatment
Who cannot join
- Systemic diseases affecting growth, bone metabolism, or craniofacial development
- Craniofacial syndromes or congenital anomalies
- Severe behavioral or cooperation problems
- Previous orthodontic or orthopedic maxillary expansion
- Patients undergoing medications that affect bone metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Fatih, 34093
Banu Kılıç, Associate Professor, +90 532 243 2756, bkilic@bezmialem.edu.tr
About this study
Official title: Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods
This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.
Read the detailed description
Maxillary transverse deficiency is a common craniofacial problem that often presents with posterior crossbite and dental crowding. Rapid Maxillary Expansion (RME) achieves sutural separation and bone remodeling, typically activated at 0.5 mm per day. Invisalign® Palatal Expander (IPE) is a modern digital system using 3D printing to produce removable nylon expanders adapted to palatal curvature, with 0.25 mm activations, simplifying oral hygiene and eliminating screw activation.
This controlled prospective clinical trial will recruit 60 children with maxillary transverse deficiency. Participants will be assigned to three groups: IPE (n=20), RME (n=20), and untreated control (n=20). Intraoral scans will be obtained at the end of expansion, at 3 months, and at 6 months to create three-dimensional digital models. Maxillary dental arch widths, first molar angulations, palatal surface areas, and volumes will be measured. Extraoral 3D facial scans will evaluate soft tissue changes, including nasal tip, alar width, and interzygomatic distance.
Statistical analyses will be performed using SPSS, applying t-tests for intra- and inter-group comparisons. The study aims to provide comparative data on a traditional (RME) and a contemporary digital (IPE) maxillary expansion method. No prior studies have directly compared these two techniques in children.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- Invisalign Palatal Expander (IPE), Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
- Keywords
- Maxillary Expansion, Rapid Maxillary Expansion (RME), Invisalign Palatal Expander (IPE), Transverse Maxillary Deficiency, Three-Dimensional Evaluation, Orthodontics, Pediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign Palatal Expander (IPE)Device
A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.
Acrylic Cap Splint Rapid Maxillary Expansion (RME) ApplianceDevice
Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.
| Study group | Role | What they receive |
|---|---|---|
| IPE Group | Experimental | Participants in this group will receive treatment with the Invisalign Palatal Expander (IPE). Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Receives: Device: Invisalign Palatal Expander (IPE) |
| RME Group | Experimental | Participants in this group will receive treatment with an acrylic cap splint Rapid Maxillary Expansion (RME) appliance. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Receives: Device: Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance |
| Control Group | No intervention | Participants in this group will not receive orthodontic expansion treatment during the study period and will serve as untreated controls. 3D intraoral and extraoral scans will be obtained at the same time points as treatment groups (end of expansion period equivalent, 3 months, 6 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maxillary First Molar Tipping
The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.
Measured: Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start20 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary Transverse DeficiencyStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Büşra Zeynep Yörük
- Sponsor type
- University, hospital or other
- Collaborators
- Centerdent Orthodontics & Aesthetic Dentistry Clinic
- Responsible party
- Sponsor-investigator, Büşra Zeynep Yörük, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262892
- Sponsor's protocol ID
- E.181356
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from this study, including intraoral and extraoral 3D scans, radiographs will be made available to other researchers upon reasonable request. All data will be anonymized to protect patient confidentiality. Access requests will be reviewed by the principal investigator, and researchers will be required to sign a data use agreement to ensure appropriate and secure use of the data.
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 39066746Turker G, Coban G, Bayraktar AU, Kurt G, Kilic E, Alkan A. Three-dimensional palatal morphology and upper arch changes following nonsurgical and surgical maxillary expansion in adults. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Oct;134(4):425-431. doi: 10.1016/j.oooo.2022.02.013. Epub 2022 Mar 3.
PubMed 35490136
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods
- ClinicalTrials.gov ID
- NCT07262892
- Acronym / sponsor ID
- E.181356
- Conditions
- Maxillary Transverse Deficiency
- Keywords
- Maxillary Expansion, Rapid Maxillary Expansion (RME), Invisalign Palatal Expander (IPE), Transverse Maxillary Deficiency, Three-Dimensional Evaluation, Orthodontics, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Büşra Zeynep YörükUniversity, hospital or other
- Collaborators
- Centerdent Orthodontics & Aesthetic Dentistry Clinic
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Dec 2025 (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 controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.
Detailed description
Maxillary transverse deficiency is a common craniofacial problem that often presents with posterior crossbite and dental crowding. Rapid Maxillary Expansion (RME) achieves sutural separation and bone remodeling, typically activated at 0.5 mm per day. Invisalign® Palatal Expander (IPE) is a modern digital system using 3D printing to produce removable nylon expanders adapted to palatal curvature, with 0.25 mm activations, simplifying oral hygiene and eliminating screw activation.
This controlled prospective clinical trial will recruit 60 children with maxillary transverse deficiency. Participants will be assigned to three groups: IPE (n=20), RME (n=20), and untreated control (n=20). Intraoral scans will be obtained at the end of expansion, at 3 months, and at 6 months to create three-dimensional digital models. Maxillary dental arch widths, first molar angulations, palatal surface areas, and volumes will be measured. Extraoral 3D facial scans will evaluate soft tissue changes, including nasal tip, alar width, and interzygomatic distance.
Statistical analyses will be performed using SPSS, applying t-tests for intra- and inter-group comparisons. The study aims to provide comparative data on a traditional (RME) and a contemporary digital (IPE) maxillary expansion method. No prior studies have directly compared these two techniques in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPE Group | Experimental | Device: Invisalign Palatal Expander (IPE)Participants in this group will receive treatment with the Invisalign Palatal Expander (IPE). Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. |
| RME Group | Experimental | Device: Acrylic Cap Splint Rapid Maxillary Expansion (RME) ApplianceParticipants in this group will receive treatment with an acrylic cap splint Rapid Maxillary Expansion (RME) appliance. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. |
| Control Group | No intervention | –Participants in this group will not receive orthodontic expansion treatment during the study period and will serve as untreated controls. 3D intraoral and extraoral scans will be obtained at the same time points as treatment groups (end of expansion period equivalent, 3 months, 6 months). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-12 years
- Good oral hygiene and adequate patient cooperation
- No previous orthodontic expansion treatment
Key exclusion criteria (5 listed)
- Systemic diseases affecting growth, bone metabolism, or craniofacial development
- Craniofacial syndromes or congenital anomalies
- Severe behavioral or cooperation problems
- Previous orthodontic or orthopedic maxillary expansion
- Patients undergoing medications that affect bone metabolism
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 Palatal Expander (IPE)A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention. | Device | IPE Group |
| Acrylic Cap Splint Rapid Maxillary Expansion (RME) ApplianceBonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice. | Device | RME Group |
Primary outcome
Change in Maxillary First Molar Tipping
Time frame: Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)
The angulation of the maxillary first molars will be measured using three-dimensional digital models obtained at T0, at 3 months after completion of expansion (T1), and at the 6-month retention follow-up (T2). Angular changes will be calculated through superimposition of maxillary 3D models and standardized angular measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: 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.
- Results publication: PubMed 35490136Turker G, Coban G, Bayraktar AU, Kurt G, Kilic E, Alkan A. Three-dimensional palatal morphology and upper arch changes following nonsurgical and surgical maxillary expansion in adults. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Oct;134(4):425-431. doi: 10.1016/j.oooo.2022.02.013. Epub 2022 Mar 3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) from this study, including intraoral and extraoral 3D scans, radiographs will be made available to other researchers upon reasonable request. All data will be anonymized to protect patient confidentiality. Access requests will be reviewed by the principal investigator, and researchers will be required to sign a data use agreement to ensure appropriate and secure use of the data.
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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.
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 Palatal Expander (IPE) and Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance in people with Maxillary Transverse Deficiency, run by Büşra Zeynep Yörük at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Banu Kılıç, Associate Professor (+90 532 243 2756, bkilic@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maxillary First Molar Tipping (time frame: Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)). 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 NCT07262892, which also lists 2 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 4 Dec 2025.