CompletedNot Applicable

Investigation of Skeletally Anchored Expansion of the Maxilla

Hungary50 participantsStarted 2025-01-06

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Skeletal maxillary expansion measured with 3D scans

Timeframe: Baseline to 6 months after completion of maxillary expansion.

Trial details

NCT IDNCT07383376

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-19

View on ClinicalTrials.gov More Palatal Expansion Technique trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.