Palatal Expansion TechniqueNCT07383376
Investigation of Skeletally Anchored Expansion of the Maxilla
A study testing MARPE and SARME in people with Palatal Expansion Technique, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study aims to compare two different methods for maxillary expansion in adult patients with transverse maxillary deficiency. Participants will receive either miniscrew-assisted rapid palatal expansion (MARPE-MICRO-4). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palatal Expansion Technique
- What is being tested?
- MARPE and SARME
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHungary
- Study dates
- 6 Jan 2025to 13 Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of transverse maxillary deficiency requiring maxillary expansion
- Indication for either non-surgical (MARPE) or surgically assisted (SARPE) maxillary expansion
- Permanent dentition
- Ability to understand the study procedures and provide informed consent
Who cannot join
- Previous maxillary expansion treatment
- Craniofacial syndromes or cleft lip/palate
- Severe periodontal disease
- Active oral infection
- Systemic conditions affecting bone metabolism
- Pregnancy or breastfeeding
- Inability to comply with study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Pediatric Dentistry and Orthodontics, Semmelweis University
Budapest, Pest County, 1088
About this study
Official title: Investigation of the Functional, Aesthetic, and Quality-of-life Effects of Combined Surgical-orthodontic Treatment
This study aims to compare two different methods for maxillary expansion in adult patients with transverse maxillary deficiency. Participants will receive either miniscrew-assisted rapid palatal expansion (MARPE-MICRO-4). We want to compare the surgically assisted rapid palatal expansion (SARPE) and the non surgical/conservative method. Clinical (3D scans of the upper jaws) measurements will be used to evaluate skeletal expansion and stability over time. Approximately 90 adult patients will be included and followed for 12 months. The results of this study may help clinicians choose the most appropriate treatment method for adult maxillary expansion.
- Conditions
- Palatal Expansion Technique
- Being tested
- MARPE, SARME
- Keywords
- maxillary expansion, orthodontics, occlusion
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARPEDevice
Miniscrew-assisted rapid palatal expander (MARPE)
SARMEProcedure or surgery
Surgically assisted rapid palatal expansion (SARPE).
| Study group | Role | What they receive |
|---|---|---|
| Surgically Assisted Rapid Maxillary Expansion | Active comparator | Participants in this arm will undergo surgically assisted rapid palatal expansion (SARPE). The procedure will include surgical weakening of the maxillary sutures followed by maxillary expansion using a palatal expansion appliance. The appliance will be activated according to a standardized protocol. Clinical and radiographic assessments will be performed to evaluate treatment outcomes. Receives: Procedure: SARME |
| Non-Surgically Assisted Rapid Maxillary Expansion | Experimental | Participants in this arm will undergo non-surgical maxillary expansion using a miniscrew-assisted rapid palatal expansion (MARPE) appliance. The appliance will be anchored to the palate using temporary anchorage devices (TADs) and activated according to a standardized expansion protocol. No surgical assistance will be performed in this group. Clinical and radiographic assessments will be used to evaluate treatment outcomes. Receives: Device: MARPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal maxillary expansion measured with 3D scans
Changes in intermolar and intercanine width will be measured on digital dental models.
Measured: Baseline to 6 months after completion of maxillary expansion.
Secondary outcomes (1)
Buccal tipping of posterior teeth measured on 3D digital models
Buccal tipping of posterior teeth will be assessed using 3D digital dental models by measuring changes in crown inclination of maxillary premolars and molars before treatment and after completion of maxillary expansion.
Measured: Baseline to 6 months after completion of maxillary expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start6 Jan 2025
- Primary completion19 Mar 2025
- Study completion13 Nov 2025
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 Semmelweis 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PICO
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383376
- Sponsor's protocol ID
- SE RKEB 249/2024
- Status last verified
- Dec 2025
- First submitted
- 26 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request after publication of the primary results. Requests will be reviewed by the study investigators and data will be provided in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Functional, Aesthetic, and Quality-of-life Effects of Combined Surgical-orthodontic Treatment
- ClinicalTrials.gov ID
- NCT07383376
- Acronym / sponsor ID
- SE RKEB 249/2024
- Conditions
- Palatal Expansion Technique
- Keywords
- maxillary expansion, orthodontics, occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 3 Feb 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.
This study aims to compare two different methods for maxillary expansion in adult patients with transverse maxillary deficiency. Participants will receive either miniscrew-assisted rapid palatal expansion (MARPE-MICRO-4). We want to compare the surgically assisted rapid palatal expansion (SARPE) and the non surgical/conservative method. Clinical (3D scans of the upper jaws) measurements will be used to evaluate skeletal expansion and stability over time. Approximately 90 adult patients will be included and followed for 12 months. The results of this study may help clinicians choose the most appropriate treatment method for adult maxillary expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PICO
| Arm | Type | Receives |
|---|---|---|
| Surgically Assisted Rapid Maxillary Expansion | Active comparator | Procedure: SARMEParticipants in this arm will undergo surgically assisted rapid palatal expansion (SARPE). The procedure will include surgical weakening of the maxillary sutures followed by maxillary expansion using a palatal expansion appliance. The appliance will be activated according to a standardized protocol. Clinical and radiographic assessments will be performed to evaluate treatment outcomes. |
| Non-Surgically Assisted Rapid Maxillary Expansion | Experimental | Device: MARPEParticipants in this arm will undergo non-surgical maxillary expansion using a miniscrew-assisted rapid palatal expansion (MARPE) appliance. The appliance will be anchored to the palate using temporary anchorage devices (TADs) and activated according to a standardized expansion protocol. No surgical assistance will be performed in this group. Clinical and radiographic assessments will be used to evaluate treatment outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of transverse maxillary deficiency requiring maxillary expansion
- Indication for either non-surgical (MARPE) or surgically assisted (SARPE) maxillary expansion
- Permanent dentition
- Ability to understand the study procedures and provide informed consent
Key exclusion criteria (7 listed)
- Previous maxillary expansion treatment
- Craniofacial syndromes or cleft lip/palate
- Severe periodontal disease
- Active oral infection
- Systemic conditions affecting 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 |
|---|---|---|
| MARPEMiniscrew-assisted rapid palatal expander (MARPE) | Device | Non-Surgically Assisted Rapid Maxillary Expansion |
| SARMESurgically assisted rapid palatal expansion (SARPE). | Procedure or surgery | Surgically Assisted Rapid Maxillary Expansion |
Primary outcome
Skeletal maxillary expansion measured with 3D scans
Time frame: Baseline to 6 months after completion of maxillary expansion.
Changes in intermolar and intercanine width will be measured on digital dental models.
1 secondary outcome
Buccal tipping of posterior teeth measured on 3D digital models
Time frame: Baseline to 6 months after completion of maxillary expansion
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request after publication of the primary results. Requests will be reviewed by the study investigators and data will be provided in accordance with institutional and ethical regulations.
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Palatal Expansion Technique
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 MARPE and SARME in people with Palatal Expansion Technique, run by Semmelweis University at 1 site in Hungary.
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 4 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 26 Aug 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 Hungary. 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?
Skeletal maxillary expansion measured with 3D scans (time frame: Baseline to 6 months after completion of maxillary expansion.). 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 26 Aug 2026.