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OpenTrials
Completed

NCT Number: NCT07383376

Investigation of Skeletally Anchored Expansion of the Maxilla

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Dentistry and Orthodontics, Semmelweis University

Budapest, Pest County, 1088, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MARPE

Device

Miniscrew-assisted rapid palatal expander (MARPE)

SARME

Procedure

Surgically assisted rapid palatal expansion (SARPE).

Primary outcomes

  1. Skeletal maxillary expansion measured with 3D scans

    Time frame: Baseline to 6 months after completion of maxillary expansion.

    Changes in intermolar and intercanine width will be measured on digital dental models.

Secondary outcomes

  1. Buccal tipping of posterior teeth measured on 3D digital models

    Time frame: Baseline to 6 months after completion of maxillary expansion

    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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Investigation of the Functional, Aesthetic, and Quality-of-life Effects of Combined Surgical-orthodontic Treatment

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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