Palatal Expansion TechniqueNCT06246656
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
A study testing Maxillary Expansion in people with Palatal Expansion Technique, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance. Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance. Read more about this study
- Who is it for?
- Ages 12 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Palatal Expansion Technique
- What is being tested?
- Maxillary Expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jan 2025to 1 Sep 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 12 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Maxillary transverse deficit,
- Lateral crossbite
Who cannot join
- Previous orthodontic treatment,
- Craniofacial anomalies,
- Severe facial asymmetries,
- Pregnancy,
- Periodontal lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Orthodontics
Vienna, State of Vienna, 1090
Alexander Schwärzler DMD Prinzipal Investigator, DMD, +436649222987, alexander.schwaerzler@meduniwien.ac.at
About this study
Official title: Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
- Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
- Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
- Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
- Placement of guided orthodontic TADs (Temporary Anchorage Devices)
- Skeletal expansion using CAD/CAM appliance
- Fixed multibracket appliance in the upper and lower jaw
- Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
Read the detailed description
This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
Intraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.
These examinations do not involve pain and are performed during regular follow-up appointments.
- Conditions
- Palatal Expansion Technique
- Being tested
- Maxillary Expansion
- Keywords
- CAD/CAM, Orthodontics, Maxillary Expansion, Soft Tissue Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary ExpansionProcedure or surgery
Palatal Expansion using a CAD/CAM appliance
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM milled TAD guides | Active comparator | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling. Receives: Procedure: Maxillary Expansion |
| 3D printed guides | Active comparator | The position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology. Receives: Procedure: Maxillary Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
Comparison of midfacial landmark changes during maxillary expansion
Measured: up to six months
Secondary outcomes (1)
CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.
Transfer accuracy of milled and 3D printed drilling templates
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palatal Expansion TechniqueStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Schwaerzler, DMD, Medical University of Vienna
- Investigators
- Xiaohui Rausch-Fan, Prof., Study director, Center of Clinical Research, University Clinic of Dentistry, Medical University of ViennaAlexander Schwärzler, DMD, Principal investigator, Department of Orthodontics, University Clinic of Dentistry, Medical University of ViennaErwin Jonke, Prof., Study chair, Department of Orthodontics, University Clinic of Dentistry, Medical University of ViennaSophia Panwinkler, DMD, Principal investigator, Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246656
- Sponsor's protocol ID
- 1804/2022
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2023
- Last updated
- 5 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Changes During Maxillary Expansion Using Skeletally Anchored Appliances: a Prospective, Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT06246656
- Acronym / sponsor ID
- 1804/2022
- Conditions
- Palatal Expansion Technique
- Keywords
- CAD/CAM, Orthodontics, Maxillary Expansion, Soft Tissue Change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Feb 2024 (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.
- Hard tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
- Soft tissue changes during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
Participants will undergo orthodontic treatment, including:
- Initial records (intraoral scan, CBCT (cone-beam computed tomography) scan, face scan)
- Placement of guided orthodontic TADs (Temporary Anchorage Devices)
- Skeletal expansion using CAD/CAM appliance
- Fixed multibracket appliance in the upper and lower jaw
- Intermediate and terminal documents (intraoral scan, CBCT scan, face scan)
Detailed description
This clinical trial aims to evaluate the influence of maxillary expansion using a CAD/CAM-manufactured appliance impact on the soft and hard tissues in the midfacial region in adolescent and adult orthodontic patients.
This study aims to evaluate how this treatment changes the bony structures and soft tissues (for example, the nose) in the mid-facial region during the transversal expansion of the maxilla using a CAD/CAM expansion appliance.
The appliance consists of two anchorage elements on the first molars and two TADs. The mini-screws are placed on the palate under local anesthesia with the help of drilling templates.
CAD/CAD milled and 3D printed guides will be used for the placement of the TADs.
The study will be conducted on orthodontic patients between 12 and 26 years who will receive fixed orthodontic braces in the upper and lower jaw and show a width deficit of the upper jaw.
Intraoral, face, and computed tomography (CT) scans will be used for the investigation. An intraoral and face scanner enables a high-resolution 3D image of the teeth and face. A CBCT Scan is a three-dimensional X-ray image.
These examinations do not involve pain and are performed during regular follow-up appointments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM milled TAD guides | Active comparator | Procedure: Maxillary ExpansionThe position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by CAD/CAM milling. |
| 3D printed guides | Active comparator | Procedure: Maxillary ExpansionThe position guides for orthodontic Temporary Anchorage Devices (TAD) will be produced by 3D printing technology. |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Maxillary transverse deficit,
- Lateral crossbite
Key exclusion criteria (5 listed)
- Previous orthodontic treatment,
- Craniofacial anomalies,
- Severe facial asymmetries,
- Pregnancy,
- Periodontal lesions
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 |
|---|---|---|
| Maxillary ExpansionPalatal Expansion using a CAD/CAM appliance | Procedure or surgery | 3D printed guides, CAD/CAM milled TAD guides |
Primary outcome
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans.
Time frame: up to six months
Comparison of midfacial landmark changes during maxillary expansion
1 secondary outcome
CAD/CAM milled versus 3D printed guides for orthodontic TADs compared by the millimetric and angular deviation of planned and clinical position.
Time frame: up to 4 weeks
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 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Palatal Expansion Technique
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Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
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Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition
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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.
Xiaohui Rausch-Fan, Prof. study director
Center of Clinical Research, University Clinic of Dentistry, Medical University of Vienna
Alexander Schwärzler, DMD principal investigator
Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
Erwin Jonke, Prof. study chair
Department of Orthodontics, University Clinic of Dentistry, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Expansion in people with Palatal Expansion Technique, run by Medical University of Vienna at 1 site in Austria.
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 2 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 5 Sep 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 Austria. 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 Sophia Panwinkler, DMD (+431400704301, sophia.panwinkler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Millimetric landmark changes of hard and soft tissue measured by the digital superimposition of CBCT Scans. (time frame: up to six months). 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 Sep 2025.