Evaluation of Maxillary Expansion Methods on Nasomaxillary Structures

NCT07326345 | Recruiting

• 1 other identifier: E.211679
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillary Expansion; Maxillary Transverse Deficiency

Outcome Measures

Primary Outcomes (3)

• Changes in Craniofacial Volumes

  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

  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

  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).

Study Arms (2)

Mini Screw-Supported Rapid Maxillary Expansion (MARPE) Group

EXPERIMENTAL

Device: MARPE (Mini-Screw Assisted Rapid Palatal Expansion)

Surgical-Assisted Rapid Maxillary Expansion (SARME) Group

EXPERIMENTAL

Procedure: SARME (Surgically Assisted Rapid Maxillary Expansion)

Interventions

SARME (Surgically Assisted Rapid Maxillary Expansion) PROCEDURE

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.

Surgical-Assisted Rapid Maxillary Expansion (SARME) Group

MARPE (Mini-Screw Assisted Rapid Palatal Expansion) DEVICE

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.

Mini Screw-Supported Rapid Maxillary Expansion (MARPE) Group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of maxillary transverse deficiency.
• Patients aged 15 years and older.
• Presence of unilateral or bilateral crossbite.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merve Kulaksız: lead

Study Sites (1)

Bezmialem Vakif University Faculty of Dentistry, Department of Orthodontics

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Merve Kulaksız, PhD Student

CONTACT

+90 539 326 36 16; dtmervekulaksiz@gmail.com

Şerife Şahin, Assistant Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student, Department of Orthodontics

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 8, 2026
• Study Start: September 29, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)