- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326345
Evaluation of Maxillary Expansion Methods on Nasomaxillary Structures
January 2, 2026 updated by: Merve Kulaksız
Evaluation of the Effects of Different Rapid Maxillary Expansion Methods on the Nasomaxillary Complex Structures
Maxillary transverse deficiency is an orthodontic anomaly characterized by the upper and lower dental arches being incompatible due to insufficient width of the maxilla.
This condition typically manifests with clinical symptoms such as crossbite, crowding of teeth, and impaired respiratory function.
Genetic factors, early primary tooth loss, mouth breathing, thumb sucking, and abnormal swallowing are among the causes of maxillary narrowing.
Treatment options vary depending on the patient's age and the degree of suture closure.
In pediatric and adolescent patients, rapid (RPE) or slow (SPE) orthodontic expansion can be achieved with palatal expansion appliances.
However, in adult patients, due to the less flexible bone structure of the maxilla, methods such as surgically assisted expansion (SARME) or mini-screw-assisted expansion (MARPE) are preferred.
Recent studies have shown that MARPE can be effective as a non-surgical alternative in young adults and can provide direct skeletal expansion without damaging the teeth.
Study Overview
Status
Recruiting
Detailed Description
Thirty patients with maxillary transverse narrowing will be divided into two groups, MARPE and SARME, based on the amount of expansion required and suture ossification.
Hybrid appliances will be custom-made for 15 patients undergoing mini-screw-supported rapid maxillary expansion.
The position and number of screws will be determined individually for each patient.
The screws to be used will have a diameter of 2 mm and a length of 14 mm.
The screws will be placed under local anesthesia.
A minimum of 2 and a maximum of 4 screws will be applied to patients.
In the group undergoing surgical-assisted rapid maxillary expansion, expansion will be applied using an acrylic cap splint.
In the SARME group, patients will undergo a standard Le Fort 1 osteotomy under general anesthesia.
The appliances in both groups will be removed after a 6-month retention period.
Cone beam computed tomography (90 kVp; 10 mA; 200 mm Voxel Size) will be taken from patients in both groups before starting the expansion treatment (T0) and after the 6-month retention period.
Measurements will be performed on these radiological images using the Planmeca Romexis program.
The volume, anteroposterior diameter, transverse diameter, length, and angle of the nasolacrimal canal and nasopalatine canal will be measured before and after treatment.
The volume of the maxillary sinus and the diameter of the ostium openings will be measured.
The nasal breathing volume and septal deviation will be measured on CBCT before treatment (T0) and at the end of the retention period (T1), and the results will be compared.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merve Kulaksız, PhD Student
- Phone Number: +90 539 326 36 16
- Email: dtmervekulaksiz@gmail.com
Study Contact Backup
- Name: Şerife Şahin, Assistant Professor
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey (Türkiye), 34093
- Recruiting
- Bezmialem Vakif University Faculty of Dentistry, Department of Orthodontics
-
Contact:
- Merve Kulaksız, PhD Student
- Phone Number: +905393263616
- Email: mervekulaksiiz@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of maxillary transverse deficiency.
- Patients aged 15 years and older.
- Presence of unilateral or bilateral crossbite.
Exclusion Criteria:
- Severe facial deformities or craniofacial syndromes.
- History of previous orthodontic treatment.
- Existing pathology or history of surgery related to the paranasal sinuses, nasolacrimal system, or orbital cavity.
- Inadequate patient cooperation.
- History of trauma, or previous maxillofacial/plastic surgery procedures.
- Clinical signs or symptoms of maxillary sinus pathology (e.g., maxillary sinus cysts, sinusitis).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mini Screw-Supported Rapid Maxillary Expansion (MARPE) Group
|
A mini-screw assisted rapid palatal expansion device used to achieve skeletal maxillary expansion through bicortical anchorage.
The device delivers orthopedic forces to the maxillary sutures with reduced dental tipping and greater skeletal effects compared to conventional rapid palatal expansion appliances.
|
|
Experimental: Surgical-Assisted Rapid Maxillary Expansion (SARME) Group
|
A surgically assisted maxillary expansion procedure performed to facilitate skeletal expansion in skeletally mature patients.
The procedure involves weakening areas of resistance in the maxilla (e.g., lateral walls, midpalatal suture) followed by activation with a rapid palatal expansion device to achieve transverse maxillary widening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Craniofacial Volumes
Time Frame: Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).
|
Evaluation of volumetric changes using CBCT analysis.
Specific measurements include the total volume of the nasolacrimal and nasopalatine canals, maxillary sinus volume, and nasal airway volume.
|
Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).
|
|
Changes in Linear Dimensions of Canals and Ostium
Time Frame: Before expansion (T0) and after 6-month retention (T1).
|
Assessment of linear changes including the anteroposterior and transverse diameters and lengths of the nasolacrimal and nasopalatine canals.
Additionally, the diameter of the maxillary sinus ostium openings will be measured in millimeters.
|
Before expansion (T0) and after 6-month retention (T1).
|
|
Changes in Angulation and Septal Deviation
Time Frame: Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).
|
Assessment of angular changes in craniofacial structures.
This includes the angulation of the nasolacrimal and nasopalatine canals and the degree of nasal septal deviation.
|
Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
December 12, 2025
First Submitted That Met QC Criteria
January 2, 2026
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 2, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- E.211679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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