Maxillary Transverse DeficiencyNCT07586163
Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
A study testing Invisalign Palatal Expander Therapy, In-House Clear Aligner Therapy (2-Day Protocol) and In-House Clear Aligner Therapy (5-Day Protocol) in people with Maxillary Transverse Deficiency, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
he primary aim of this study is to compare the dentoalveolar and skeletal effects of arch expansion using an in-house clear aligner system, produced chairside with an indirect manufacturing technique, and commercially available clear aligner systems (Invisalign) in patients during the mixed dentition period. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- Invisalign Palatal Expander Therapy, In-House Clear Aligner Therapy (2-Day Protocol) and In-House Clear Aligner Therapy (5-Day Protocol)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2025to 12 Aug 2026
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in the early mixed dentition period;
- Maxillary intermolar width ≤ 31 mm;
- Presence of at least 5 mm transverse discrepancy between the maxillary and mandibular arches;
- Normal vertical growth pattern (Sn-GoGn: 32 ± 6°);
- Eruption of permanent first molars and central incisors;
- Presence of at least two primary posterior teeth in each quadrant;
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- Posterior teeth with a clinical crown height of at least 4 mm;
- Patients aged between 7 and 10 years;
- Absence of any craniofacial anomalies;
- Good oral hygiene status; Healthy periodontal tissues.
Who cannot join
- Patients with the loss of more than one primary tooth
- Presence of stainless steel crowns on the maxillary permanent first molars, primary first molars, or primary second molars
- Patients with systemic or syndromic conditions
- Presence of palatal exostoses or morphological anomalies of the palatal surface
- Presence of active temporomandibular joint disorders
- Children with poor compliance
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- History of allergy to any dental material
- Patients with multiple and/or advanced caries, tooth agenesis, or supernumerary teeth
- Patients with skeletal asymmetry
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry
Talas, Kayseri, 38039
About this study
Official title: Comparison of the Effectiveness of Different Clear Aligner Systems in Patients With Maxillary Transverse Deficiency During the Mixed Dentition Period: An In-Vivo Randomized Controlled Clinical Trial
he primary aim of this study is to compare the dentoalveolar and skeletal effects of arch expansion using an in-house clear aligner system, produced chairside with an indirect manufacturing technique, and commercially available clear aligner systems (Invisalign) in patients during the mixed dentition period.
Participants will be allocated into five groups: Group A-In-house aligners (5-day activation protocol), Group B-In-house aligners (2-day activation protocol), Group C-Invisalign First aligners, Group D-Invisalign Palatal Expander, and Group E-untreated control group.
Read more
Before treatment, demographic data, dental models, intraoral and extraoral photographs, radiographic images, and clinical measurements will be collected. Skeletal measurements, including maxillary and nasal widths, will be evaluated using posteroanterior cephalometric radiographs. Digital models of the maxilla and mandible will be obtained using an intraoral scanner and used for dental measurements before and after treatment.
Secondary outcomes include evaluation of facial soft tissue changes using stereophotogrammetry (3DMD), assessment of white spot lesions using quantitative light-induced fluorescence (QLF), and analysis of patient compliance using the Orthodontic Patient Cooperation Scale. In addition, changes in body mass index (BMI), maxillary-mandibular transverse discrepancies, and appliance wear time will be evaluated.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- Invisalign Palatal Expander Therapy, In-House Clear Aligner Therapy (2-Day Protocol), In-House Clear Aligner Therapy (5-Day Protocol), Invisalign First Aligner Therapy
- Keywords
- Clear aligners, Mixed dentition, Maxillary expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign Palatal Expander TherapyDevice
In patients treated with the Invisalign Palatal Expander (IPE) (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (iTero Lumina™, Align Technology). Individualized maxillary expansion amounts were prescribed based on clinical objectives. Unlike conventional aligner therapy, the IPE system does not involve full digital treatment simulation; expansion was defined by the planned transverse increase. Following approval, customized IPE appliance sets were manufactured and delivered. Patients were instructed to wear the appliance full-time, including during meals, removing it only for oral hygiene procedures. The activation protocol consisted of appliance changes every 2 days, providing 0.25 mm transverse expansion per stage. After completion of expansion, retention was achieved using Invisalign Palatal Holder appliances fabricated from new digital scans.
In-House Clear Aligner Therapy (2-Day Protocol)Device
In-house clear aligners were fabricated using a fully digital workflow. Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning. Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars. Maxillary models were digitally expanded in 0.2 mm increments per stage, generating sequential STL files. Models were 3D-printed and thermoformed to fabricate aligners, which were then trimmed, polished, and labeled. Patients received five aligners at each visit and were instructed to change them every 2 days. Follow-up visits were scheduled at 10-day intervals. At each visit, treatment progress was assessed, and the next series of aligners was provided.
In-House Clear Aligner Therapy (5-Day Protocol)Device
In-house clear aligners were fabricated using a fully digital workflow. Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning. Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars to enhance retention and support transverse expansion. Models were digitally expanded in 0.2 mm increments per stage and converted into sequential STL files. These models were 3D-printed (Asiga MAX UV) and thermoformed (MINISTAR S) to produce aligners. The appliances were trimmed, polished, and labeled with sequence numbers. Patients received five aligners per visit and were instructed to change them every 5 days. Follow-up visits were scheduled at 25-day intervals, during which treatment progress was evaluated and new aligners were delivered.
Invisalign First Aligner TherapyDevice
In patients treated with Invisalign First (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (3Shape TRIOS). Intraoral, extraoral photographs and radiographs were collected and uploaded to the ClinCheck digital treatment planning platform. Individualized treatment objectives were defined, and expansion was planned without concurrent tooth movement to isolate maxillary transverse effects. After achieving the desired expansion, comprehensive orthodontic treatment was continued. Virtual treatment plans were reviewed and revised when necessary before approval. Attachments were placed on posterior teeth to enhance retention and support expansion. Enamel surfaces were etched, bonded, and light-cured using standard orthodontic protocols. Patients were instructed to wear aligners 20-22 hours daily,and aligners were replaced every 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Invisalign Palatal Expander | Experimental | Not described Receives: Device: Invisalign Palatal Expander Therapy |
| In-House Aligner (2-Day Protocol) | Experimental | Not described Receives: Device: In-House Clear Aligner Therapy (2-Day Protocol) |
| In-House Aligner (5-Day Protocol) | Experimental | Not described Receives: Device: In-House Clear Aligner Therapy (5-Day Protocol) |
| Invisalign First Aligner | Active comparator | Not described Receives: Device: Invisalign First Aligner Therapy |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Transverse Dentoalveolar Dimension
Measured: 20 weeks
Secondary outcomes (1)
White spot lesion incidence
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start26 May 2025
- Primary completion7 Jul 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Transverse DeficiencyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celal Irgin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586163
- Sponsor's protocol ID
- 2025/189
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Different Clear Aligner Systems in Patients With Maxillary Transverse Deficiency During the Mixed Dentition Period: An In-Vivo Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07586163
- Acronym / sponsor ID
- 2025/189
- Conditions
- Maxillary Transverse Deficiency
- Keywords
- Clear aligners, Mixed dentition, Maxillary expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 14 May 2026 (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.
he primary aim of this study is to compare the dentoalveolar and skeletal effects of arch expansion using an in-house clear aligner system, produced chairside with an indirect manufacturing technique, and commercially available clear aligner systems (Invisalign) in patients during the mixed dentition period.
Participants will be allocated into five groups: Group A-In-house aligners (5-day activation protocol), Group B-In-house aligners (2-day activation protocol), Group C-Invisalign First aligners, Group D-Invisalign Palatal Expander, and Group E-untreated control group.
Before treatment, demographic data, dental models, intraoral and extraoral photographs, radiographic images, and clinical measurements will be collected. Skeletal measurements, including maxillary and nasal widths, will be evaluated using posteroanterior cephalometric radiographs. Digital models of the maxilla and mandible will be obtained using an intraoral scanner and used for dental measurements before and after treatment.
Secondary outcomes include evaluation of facial soft tissue changes using stereophotogrammetry (3DMD), assessment of white spot lesions using quantitative light-induced fluorescence (QLF), and analysis of patient compliance using the Orthodontic Patient Cooperation Scale. In addition, changes in body mass index (BMI), maxillary-mandibular transverse discrepancies, and appliance wear time will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Invisalign Palatal Expander | Experimental | Device: Invisalign Palatal Expander Therapy |
| In-House Aligner (2-Day Protocol) | Experimental | Device: In-House Clear Aligner Therapy (2-Day Protocol) |
| In-House Aligner (5-Day Protocol) | Experimental | Device: In-House Clear Aligner Therapy (5-Day Protocol) |
| Invisalign First Aligner | Active comparator | Device: Invisalign First Aligner Therapy |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patients in the early mixed dentition period;
- Maxillary intermolar width ≤ 31 mm;
- Presence of at least 5 mm transverse discrepancy between the maxillary and mandibular arches;
- Normal vertical growth pattern (Sn-GoGn: 32 ± 6°);
- Eruption of permanent first molars and central incisors;
Key exclusion criteria (9 listed)
- Patients with the loss of more than one primary tooth
- Presence of stainless steel crowns on the maxillary permanent first molars, primary first molars, or primary second molars
- Patients with systemic or syndromic conditions
- Presence of palatal exostoses or morphological anomalies of the palatal surface
- Presence of active temporomandibular joint disorders
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 TherapyIn patients treated with the Invisalign Palatal Expander (IPE) (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (iTero Lumina™, Align Technology). Individualized maxillary expansion amounts were prescribed based on clinical objectives. Unlike conventional aligner therapy, the IPE system does not involve full digital treatment simulation; expansion was defined by the planned transverse increase. Following approval, customized IPE appliance sets were manufactured and delivered. Patients were instructed to wear the appliance full-time, including during meals, removing it only for oral hygiene procedures. The activation protocol consisted of appliance changes every 2 days, providing 0.25 mm transverse expansion per stage. After completion of expansion, retention was achieved using Invisalign Palatal Holder appliances fabricated from new digital scans. | Device | Invisalign Palatal Expander |
| In-House Clear Aligner Therapy (2-Day Protocol)In-house clear aligners were fabricated using a fully digital workflow. Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning. Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars. Maxillary models were digitally expanded in 0.2 mm increments per stage, generating sequential STL files. Models were 3D-printed and thermoformed to fabricate aligners, which were then trimmed, polished, and labeled. Patients received five aligners at each visit and were instructed to change them every 2 days. Follow-up visits were scheduled at 10-day intervals. At each visit, treatment progress was assessed, and the next series of aligners was provided. | Device | In-House Aligner (2-Day Protocol) |
| In-House Clear Aligner Therapy (5-Day Protocol)In-house clear aligners were fabricated using a fully digital workflow. Digital impressions were obtained with an intraoral scanner (3Shape TRIOS), and maxillary models were processed in CAD software for segmentation and attachment planning. Buccal retention attachments were placed on primary canines, primary molars, and permanent first molars to enhance retention and support transverse expansion. Models were digitally expanded in 0.2 mm increments per stage and converted into sequential STL files. These models were 3D-printed (Asiga MAX UV) and thermoformed (MINISTAR S) to produce aligners. The appliances were trimmed, polished, and labeled with sequence numbers. Patients received five aligners per visit and were instructed to change them every 5 days. Follow-up visits were scheduled at 25-day intervals, during which treatment progress was evaluated and new aligners were delivered. | Device | In-House Aligner (5-Day Protocol) |
| Invisalign First Aligner TherapyIn patients treated with Invisalign First (Align Technology, Santa Clara, CA), three-dimensional digital models were obtained using an intraoral scanner (3Shape TRIOS). Intraoral, extraoral photographs and radiographs were collected and uploaded to the ClinCheck digital treatment planning platform. Individualized treatment objectives were defined, and expansion was planned without concurrent tooth movement to isolate maxillary transverse effects. After achieving the desired expansion, comprehensive orthodontic treatment was continued. Virtual treatment plans were reviewed and revised when necessary before approval. Attachments were placed on posterior teeth to enhance retention and support expansion. Enamel surfaces were etched, bonded, and light-cured using standard orthodontic protocols. Patients were instructed to wear aligners 20-22 hours daily,and aligners were replaced every 5 days. | Device | Invisalign First Aligner |
Primary outcome
Maxillary Transverse Dentoalveolar Dimension
Time frame: 20 weeks
1 secondary outcome
White spot lesion incidence
Time frame: 20 weeks
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Invisalign Palatal Expander Therapy, In-House Clear Aligner Therapy (2-Day Protocol) and In-House Clear Aligner Therapy (5-Day Protocol) in people with Maxillary Transverse Deficiency, run by TC Erciyes University 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 10 inclusion and 9 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 30 Oct 2026. 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?
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 Transverse Dentoalveolar Dimension (time frame: 20 weeks). 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 30 Oct 2026.