Investigation of Skeletally Anchored Expansion of the Maxilla

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 40 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 Overview

• Status: Completed
• Conditions: Palatal Expansion Technique
• Intervention / Treatment: Procedure: SARME; Device: MARPE

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Pest County
    • Budapest, Pest County, Hungary, 1088
      • Department of Pediatric Dentistry and Orthodontics, Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgically Assisted Rapid Maxillary Expansion; 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.	Procedure: SARME; Surgically assisted rapid palatal expansion (SARPE).
Experimental: Non-Surgically Assisted Rapid Maxillary Expansion; 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.	Device: MARPE; Miniscrew-assisted rapid palatal expander (MARPE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal maxillary expansion measured with 3D scans	Changes in intermolar and intercanine width will be measured on digital dental models.	Baseline to 6 months after completion of maxillary expansion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months after completion of maxillary expansion

Collaborators and Investigators

• Sponsor: Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): November 13, 2025

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: occlusion; orthodontics; maxillary expansion
• Additional Relevant MeSH Terms: Wounds and Injuries; Chemically-Induced Disorders; Poisoning; Bites and Stings
• Other Study ID Numbers: SE RKEB 249/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified individual participant data and the study protocol will be available after publication of the primary results and will remain available for 5 years.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and data will be shared in accordance with institutional policies and ethical approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No