Maxillary Transverse DeficiencyMARPE-GUIDENCT07707596
Direct vs Digitally Guided Miniscrew Placement for MARPE
A study testing Direct appliance-guided miniscrew placement and Digitally guided CAD/CAM miniscrew placement in people with Maxillary Transverse Deficiency, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This randomized clinical trial compared the accuracy, primary stability, and anatomical safety of two protocols for palatal miniscrew placement in adolescents requiring maxillary skeletal expansion. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- Direct appliance-guided miniscrew placement and Digitally guided CAD/CAM miniscrew placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 20 Feb 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 and 18 years
- Transverse maxillary deficiency requiring skeletal expansion
- Midpalatal suture maturation stage B or C
- Adequate palatal bone height for miniscrew insertion (≥9 mm)
- No previous maxillary expansion treatment
Who cannot join
- Age >18 years
- Palatal bone height <6 mm
- Systemic disease affecting bone metabolism
- Medication affecting bone turnover
- Craniofacial syndromes or cleft conditions
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08017
About this study
Official title: Direct vs Digitally Guided Palatal Miniscrew Placement for MARPE: A Randomized Clinical Trial on Accuracy, Stability, and Anatomical Safety
This randomized clinical trial compared the accuracy, primary stability, and anatomical safety of two protocols for palatal miniscrew placement in adolescents requiring maxillary skeletal expansion. Participants were randomly assigned to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Postoperative CBCT imaging was used to assess placement accuracy and anatomical safety, while clinical evaluation was used to assess primary stability.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- Direct appliance-guided miniscrew placement, Digitally guided CAD/CAM miniscrew placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct appliance-guided miniscrew placementProcedure or surgery
Palatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position.
Digitally guided CAD/CAM miniscrew placementProcedure or surgery
Palatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning.
| Study group | Role | What they receive |
|---|---|---|
| Direct appliance-guided miniscrew placement | Experimental | Participants received MARPE treatment with palatal miniscrews inserted directly using the expansion appliance as the positioning guide. Receives: Procedure: Direct appliance-guided miniscrew placement |
| Digitally guided CAD/CAM miniscrew placement | Experimental | Participants received MARPE treatment with palatal miniscrews inserted using a digitally planned CAD/CAM surgical guide. Receives: Procedure: Digitally guided CAD/CAM miniscrew placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean coronal deviation between planned and achieved miniscrew position
Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Measured: Immediately after miniscrew placement
Mean apical deviation between planned and achieved miniscrew position
Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Measured: Immediately after miniscrew placement
Mean angular deviation between planned and achieved miniscrew position
Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Measured: Immediately after miniscrew placement
Secondary outcomes (2)
Number of miniscrew failures before expansion activation
Failure is defined as clinical mobility, loss of primary stability, or miniscrew loss before expansion activation. The number of failed miniscrews will be recorded in each study group.
Measured: At 8 weeks after miniscrew placement
Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT
Postoperative CBCT images will be used to evaluate whether miniscrew placement resulted in invasion of adjacent anatomical structures, including the nasal cavity or maxillary sinus. The total number of miniscrews exhibiting anatomical invasion will be recorded.
Measured: Immediately after miniscrew placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 May 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 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.
- 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
- Model description
- Participants were randomized in a 1:1 ratio to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Outcomes included placement accuracy, primary stability, and anatomical safety.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Arcos Palomino, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707596
- Sponsor's protocol ID
- UIC-MARPE-2026-01
- Acronym
- MARPE-GUIDE
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct vs Digitally Guided Palatal Miniscrew Placement for MARPE: A Randomized Clinical Trial on Accuracy, Stability, and Anatomical Safety
- ClinicalTrials.gov ID
- NCT07707596
- Acronym / sponsor ID
- MARPE-GUIDE / UIC-MARPE-2026-01
- Conditions
- Maxillary Transverse Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 16 Jul 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 randomized clinical trial compared the accuracy, primary stability, and anatomical safety of two protocols for palatal miniscrew placement in adolescents requiring maxillary skeletal expansion. Participants were randomly assigned to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Postoperative CBCT imaging was used to assess placement accuracy and anatomical safety, while clinical evaluation was used to assess primary stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either direct appliance-guided miniscrew placement for MARPE or digitally guided CAD/CAM-assisted miniscrew placement. Outcomes included placement accuracy, primary stability, and anatomical safety.
| Arm | Type | Receives |
|---|---|---|
| Direct appliance-guided miniscrew placement | Experimental | Procedure: Direct appliance-guided miniscrew placementParticipants received MARPE treatment with palatal miniscrews inserted directly using the expansion appliance as the positioning guide. |
| Digitally guided CAD/CAM miniscrew placement | Experimental | Procedure: Digitally guided CAD/CAM miniscrew placementParticipants received MARPE treatment with palatal miniscrews inserted using a digitally planned CAD/CAM surgical guide. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 12 and 18 years
- Transverse maxillary deficiency requiring skeletal expansion
- Midpalatal suture maturation stage B or C
- Adequate palatal bone height for miniscrew insertion (≥9 mm)
- No previous maxillary expansion treatment
Key exclusion criteria (5 listed)
- Age >18 years
- Palatal bone height <6 mm
- Systemic disease affecting bone metabolism
- Medication affecting bone turnover
- Craniofacial syndromes or cleft conditions
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 |
|---|---|---|
| Direct appliance-guided miniscrew placementPalatal miniscrews were inserted manually using the MARPE appliance as the insertion guide according to the planned position. | Procedure or surgery | Direct appliance-guided miniscrew placement |
| Digitally guided CAD/CAM miniscrew placementPalatal miniscrews were inserted using a tooth-supported CAD/CAM surgical guide based on digital planning. | Procedure or surgery | Digitally guided CAD/CAM miniscrew placement |
Primary outcome
Mean coronal deviation between planned and achieved miniscrew position
Time frame: Immediately after miniscrew placement
Coronal deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Mean apical deviation between planned and achieved miniscrew position
Time frame: Immediately after miniscrew placement
Apical deviation (mm) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
Mean angular deviation between planned and achieved miniscrew position
Time frame: Immediately after miniscrew placement
Angular deviation (degrees) measured on postoperative CBCT by comparing the planned and achieved miniscrew positions.
2 secondary outcomes
Number of miniscrew failures before expansion activation
Time frame: At 8 weeks after miniscrew placement
Number of miniscrews with nasal cavity or maxillary sinus invasion assessed by postoperative CBCT
Time frame: Immediately after miniscrew placement
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 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Maxillary Transverse Deficiency
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
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Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
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 Direct appliance-guided miniscrew placement and Digitally guided CAD/CAM miniscrew placement in people with Maxillary Transverse Deficiency, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 16 Jul 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 Spain. 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?
Mean coronal deviation between planned and achieved miniscrew position (time frame: Immediately after miniscrew placement). The study lists 3 primary outcomes in all. 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 16 Jul 2026.