Investigation of the Functional, Aesthetic, and Quality-of-life Effects of Combined Surgical-orthodontic Treatment
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Semmelweis University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Skeletal maxillary expansion measured with 3D scans
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SARME (Procedure)
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.
Intervention: MARPE (Device)
Outcomes
Primary Outcomes
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
- Buccal tipping of posterior teeth measured on 3D digital models(Baseline to 6 months after completion of maxillary expansion)