Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-25
SponsorAdiyaman University

About this trial

This prospective, controlled observational study aims to evaluate three-dimensional (3D) facial soft tissue changes following miniscrew-assisted rapid palatal expansion (MARPE) and determine whether these changes are clinically perceptible to orthodontic specialists and patients.

A total of 55 postpubertal participants aged 16-25 years will be included: 40 patients undergoing MARPE as part of their routine orthodontic treatment and 15 control participants who will not undergo maxillary expansion. Treatment decisions will be made independently of study participation.

Facial soft tissue changes will be assessed using 3D facial scans. The MARPE group will be scanned before expansion (T0), immediately after active expansion (T1), and three months after expansion (T2). The control group will undergo two facial scans at comparable baseline and follow-up intervals.

Changes in facial regions, including the nose, paranasal area, midface, and upper lip, will be evaluated. Blinded orthodontic specialists will assess the clinical perceptibility of changes using standardized facial images, while participants will provide their own perception of facial changes through questionnaires. When available from routine clinical records, skeletal and dental expansion measurements will also be analyzed in relation to the observed soft tissue changes.

The study aims to clarify the magnitude, distribution, and clinical relevance of facial soft tissue changes associated with MARPE.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 16-25 years.

Postpubertal skeletal maturation confirmed by cervical vertebral maturation (CVM) assessment using existing lateral cephalometric radiographs.

Patients with a clinical indication for miniscrew-assisted rapid palatal expansion (MARPE), determined independently of the study (MARPE group).

Orthodontic patients matched for age and skeletal maturation who will not undergo maxillary expansion during the observation period (control group).

Disqualifiers

History of previous maxillary expansion treatment.

Previous or planned orthognathic surgery during the observation period.

Facial aesthetic procedures or surgical interventions that may influence soft tissue morphology during follow-up.

Systemic diseases or craniofacial conditions affecting bone or soft tissue development.

Trial population

The study population will consist of 60 postpubertal orthodontic patients aged 16-25 years recruited from the Department of Orthodontics, Faculty of Dentistry, Adiyaman University, Türkiye. The MARPE group will include 40 patients undergoing clinically indicated maxillary expansion, while the control group will consist of 20 age- and skeletal maturation-matched orthodontic patients who will not receive maxillary expansion during the observation period. All participants will be prospectively followed using three-dimensional facial scans. Treatment decisions will be made independently of study participation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Miniscrew-Assisted Rapid Palatal Expansion (MARPE)

    Device

    MARPE is performed as part of routine orthodontic treatment based on an independent clinical indication. The study does not assign or modify the treatment. Three-dimensional facial scans are obtained before expansion (T0), immediately after active expansion (T1), and at the third month of retention (T2) to evaluate facial soft tissue changes.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MARPE Group1 intervention
Group B: Control Group0 interventions

Trial outcomes

Primary outcomes

1

Three-Dimensional Facial Soft Tissue Changes Following MARPE

Three-dimensional facial soft tissue changes will be evaluated using MetiSmile facial scans. Regional changes in the nasal, paranasal, midfacial, zygomatic, and upper lip areas will be quantified in millimeters (mm) by comparing baseline and follow-up scans. Changes from T0 to T2 will be compared between the MARPE and control groups. Additional changes between T0-T1 and T1-T2 will be assessed in the MARPE group.

Time frame
Baseline (T0), immediately after active expansion (T1), and 3 months after active expansion (T2). Control participants will be assessed at two corresponding time points.

Secondary outcomes

1

Expert Assessment of Perceived Facial Changes

Blinded orthodontic experts will evaluate paired three-dimensional facial images to assess the perceptibility and magnitude of facial changes. Assessments will include identification of the later time point, confidence level (0-10), perceived change severity (0-4), and facial regions showing the most noticeable changes.

Time frame
Baseline (T0) to 3 months after active expansion (T2).

Other outcomes

1

Patient-Reported Perception of Facial Changes

Participants will complete a self-assessment questionnaire to evaluate their perceived facial changes following MARPE treatment. Patient-reported perceptions will be assessed and compared with objectively measured three-dimensional facial soft tissue changes.

Time frame
3 months after active expansion (T2).

Sponsors and contacts

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