Investigation of Skeletally Anchored Expansion of the Maxilla

NCT07383376 | Completed

• 1 other identifier: SE RKEB 249/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Palatal Expansion Technique

Keywords

maxillary expansion; orthodontics; occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Buccal tipping of posterior teeth measured on 3D digital models

  Baseline to 6 months after completion of maxillary expansion

Study Arms (2)

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.

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.

Device: MARPE

Interventions

MARPE DEVICE

Miniscrew-assisted rapid palatal expander (MARPE)

Non-Surgically Assisted Rapid Maxillary Expansion

SARME PROCEDURE

Surgically assisted rapid palatal expansion (SARPE).

Surgically Assisted Rapid Maxillary Expansion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Department of Pediatric Dentistry and Orthodontics, Semmelweis University

Budapest, Pest County, 1088, Hungary

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PICO

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: January 6, 2025
• Primary Completion: March 19, 2025
• Study Completion: November 13, 2025
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

HU (1)