Investigation of Skeletally Anchored Expansion of the Maxilla

Semmelweis University

Status: Completed

Conditions: Palatal Expansion Technique

Treatments: Procedure: SARME; Device: MARPE

Study type: Interventional

Funder types: Other

Identifiers

NCT07383376

SE RKEB 249/2024

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Surgically Assisted Rapid Maxillary Expansion

Active Comparator group

Description:

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.

Treatment:

Procedure: SARME

Non-Surgically Assisted Rapid Maxillary Expansion

Experimental group

Description:

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.

Treatment:

Device: MARPE